Dilation
CRE Balloon Dilators
Controlled radial expansion balloons for GI strictures.
Compared on:
- · Diameter range
- · Balloon length
- · Catheter length
- · Wire-guided vs TTS
- · Inflation pressures
- + 1 more
471 products
Tap the circle to add to comparison · up to 4
Guidant Corp.
Unclaimed
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
No 510(k) on file
Boston Scientific Corp
Unclaimed
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
No 510(k) on file
Boston Scientific Corp
Unclaimed
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
No 510(k) on file
Endovations
Unclaimed
2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
No 510(k) on file
Ev3, Inc.
Unclaimed
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
No 510(k) on file
Guidant Corp.
Unclaimed
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393
Abbott Vascular-Vascular Solutions
Unclaimed
ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Ackrad Laboratories
Unclaimed
ACKRAD ERCP CONTRAST DELIVERY SET
No 510(k) on file
Boston Scientific Corporation
Unclaimed
Advanix Biliary Stent with NaviFlex RX Delivery System
K203162
Boston Scientific Corp
Unclaimed
ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
No 510(k) on file
Boston Scientific Corp
Unclaimed
ADVANIX DOUBLE PIGTAIL BILIARY STENT
No 510(k) on file
Boston Scientific Corporation
Unclaimed
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
K223592
Boston Scientific
Unclaimed
Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
No 510(k) on file
Boston Scientific Corporation
Unclaimed
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
No 510(k) on file
Alveolus, Inc.
Unclaimed
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
No 510(k) on file
Merit Medical Systems, Inc.
Unclaimed
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
No 510(k) on file
Intl. Medical, Inc.
Unclaimed
AMERICAN CATHETER E.R.C.P. CANNULA
No 510(k) on file
H.W. Andersen Products, Inc.
Unclaimed
AN3200 DOUBILET DRAIN
No 510(k) on file
AngioDynamics, Inc.
Unclaimed
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
No 510(k) on file
AngioDynamics, Inc.
Unclaimed
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
No 510(k) on file
AngioDynamics, Inc.
Unclaimed
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
No 510(k) on file
AngioDynamics, Inc.
Unclaimed
AngioDynamics Total Abscession Biliary Drainage Catheter
No 510(k) on file
AngioDynamics, Inc.
Unclaimed
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
No 510(k) on file
Angiomed U.S., Inc.
Unclaimed
ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
No 510(k) on file
Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)
Unclaimed
ARCHIMEDES Biodegradable Pancreatic Stent
No 510(k) on file
Ostial Corporation
Unclaimed
ARCHSTENT BILIARY SYSTEM
No 510(k) on file
Applied Vascular
Unclaimed
AVD INTIMAX (TM) BILIARY CATHETER
No 510(k) on file
Applied Vascular Devices, Inc.
Unclaimed
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Arterial Vascular Engineering, Inc.
Unclaimed
AVE BRIDGE STENT SYSTEM
K971295
Olympus Corp.
Unclaimed
BALLOON CATHETERS
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
BALLOON DILATION CATHETER
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD BALLOON DILATATION SYSTEM
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD BILIARY BALLOON DILATORS
K920361
C.R. Bard, Inc.
Unclaimed
BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
No 510(k) on file
Bard Peripheral Vascular, Inc.
Unclaimed
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
No 510(k) on file
Bard Peripheral Vascular, Inc.
Unclaimed
BARD E LUMINEXX BILIARY STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD LUMINEXX BILIARY STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD MEMOTHERM FLEXX BILIARY STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
No 510(k) on file
Bd Becton Dickinson Vacutainer Systems Preanalytic
Unclaimed
BARD-PARKER BILIARY BALLOON CATHETER
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
BARD/ANGIOMED STENTS
No 510(k) on file
GIE Medical
Unclaimed
BARE Wireguided Balloon Dilation Catheter (1235)
No 510(k) on file
Baxter Healthcare Corp
Unclaimed
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
No 510(k) on file
Medi-Globe Corp.
Unclaimed
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
No 510(k) on file
Uresil Corp.
Unclaimed
BILIARY BALLOON CATHETER
K863571
Boston Scientific Corp
Unclaimed
BILIARY BALLOON DILATATION CATHETER
No 510(k) on file
Telemed Systems, Inc.
Unclaimed
BILIARY BALLOON DILATOR
No 510(k) on file
Primrose Medical, Inc.
Unclaimed
BILIARY DIALATOR
No 510(k) on file
Schneider Intl., Ltd.
Unclaimed
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
No 510(k) on file
Porges Corp.
Unclaimed
BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
No 510(k) on file
Porges Corp.
Unclaimed
BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
No 510(k) on file
Hobbs Medical, Inc.
Unclaimed
BILIARY INDWELLING STENT
No 510(k) on file
Micro-Tech (Nanjing) Co., Ltd.
Unclaimed
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
No 510(k) on file
Menlo Care, Inc.
Unclaimed
BILIARY STENT
No 510(k) on file
Mentor Corp.
Unclaimed
BILIARY STENT PROSTHESIS
No 510(k) on file
Boston Scientific Corp
Unclaimed
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
No 510(k) on file
Telemed Systems, Inc.
Unclaimed
BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
No 510(k) on file
Bioteque Corporation
Unclaimed
BIOTEQ Drainage Catheter BT-PDS-series
No 510(k) on file
Bioteque Corporation
Unclaimed
BIOTEQ Drainage Catheter Set (One Step Type)
No 510(k) on file
Bioteque Corporation
Unclaimed
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
K251019
Bioteque Corp.
Unclaimed
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
No 510(k) on file
Endochoice, Inc.
Unclaimed
BONASTENT BILIARY
No 510(k) on file
Endochoice, Inc.
Unclaimed
BONASTENT BILIARY
No 510(k) on file
Boston Scientific Corp
Unclaimed
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
No 510(k) on file
Boston Scientific Corp
Unclaimed
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
No 510(k) on file
Boston Scientific
Unclaimed
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
BRIDGE FX
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
No 510(k) on file
Squareone
Unclaimed
BULLSEYE BILIARY STENT SYSTEM
No 510(k) on file
Mallinckrodt Critical Care
Unclaimed
BURNEY GALLBLADDER CATHETER KIT
No 510(k) on file
Cordis Corp.
Unclaimed
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
No 510(k) on file
Candela Laser Corp.
Unclaimed
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
No 510(k) on file
Catheter Technology Corp.
Unclaimed
CATH-TECH CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Boston Scientific
Unclaimed
CHARGER BALLOON DILATATION CATHETER
No 510(k) on file
Mccol Medical,Inc.
Unclaimed
CHOLANGIOGRAM CATHETER KIT
No 510(k) on file
Wiltek Medical, Inc.
Unclaimed
CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Medical Dynamics, Inc.
Unclaimed
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Compass BDS Biliary Stent
No 510(k) on file
Medtronic Vascular
Unclaimed
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264
Cook, Inc.
Unclaimed
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
No 510(k) on file
Brightwater Medical
Unclaimed
ConvertX Biliary Stent System
No 510(k) on file
Cook, Inc.
Unclaimed
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539
Cook, Inc.
Unclaimed
COOK ZILVER BILIARY STENT
No 510(k) on file
Cook, Inc.
Unclaimed
COOK-GIANTURCO BILIARY Z STENT
No 510(k) on file
Cook, Inc.
Unclaimed
COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
No 510(k) on file
Medi-Tech, Inc.
Unclaimed
COONS SOFT STENT
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS BILIARY STENT
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS NITINOL STENT AND DELIVERY SYSTEM
K980823
Cordis Europa, N.V.
Unclaimed
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
No 510(k) on file
Cordis, A Johnson & Johnson Co.
Unclaimed
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
No 510(k) on file
Cordis, A Johnson & Johnson Co.
Unclaimed
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
No 510(k) on file
Cordis Europa, N.V.
Unclaimed
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K033394
Wilson-Cook Medical, Inc.
Unclaimed
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
No 510(k) on file
Boston Scientific Corp
Unclaimed
COURIER BALLOON DILATATION CATHETER
K963691
Boston Scientific Corp
Unclaimed
COURIER ST BALLOON DILATATION CATHETER
K973008
Boston Scientific Corporation
Unclaimed
CRE DITATATION BALLON
No 510(k) on file
Boston Scientific Corporation
Unclaimed
CRE RX Biliary Balloon Dilatation Catheter
No 510(k) on file
Applied Medical Resources
Unclaimed
CYSTIC DUCT BALLOON DILATING CATHETER
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
DAVOL RETRIEVAL BALLOON CATHETER
No 510(k) on file
Mirco-Tech (Nanjing) Co., Ltd.
Unclaimed
Dilation Balloon Catheter
No 510(k) on file
Hobbs Medical, Inc.
Unclaimed
DILATION BALLOON CATHETER
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
DIRECT PERORAL CHOLANGIOSCOPY BALLOON
No 510(k) on file
Olympus Medical Systems Corporation
Unclaimed
Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
No 510(k) on file
Micro-Tech (Nanjing) Co., Ltd.
Unclaimed
Disposable Multistage Dilation Balloon Catheter
No 510(k) on file
Biosearch Medical Products, Inc.
Unclaimed
DOBBHOFF BILIARY STENT SET
No 510(k) on file
Biosearch Medical Products, Inc.
Unclaimed
DOBBHOFF(R) ERCP CANNULA
No 510(k) on file
Biosearch Medical Products, Inc.
Unclaimed
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
No 510(k) on file
Boston Scientific Corp
Unclaimed
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
No 510(k) on file
Microvasive
Unclaimed
DRAINAGE STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
No 510(k) on file
Ideas For Medicine, Inc.
Unclaimed
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
No 510(k) on file
Avantec Vascular Corp.
Unclaimed
DURAMAX .018 BILIARY STENT SYSTEM
No 510(k) on file
Avantec Vascular Corp.
Unclaimed
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
No 510(k) on file
Guidant Corp.
Unclaimed
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
No 510(k) on file
Guidant Corp.
Unclaimed
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Surgitek Medical Engineering Corp.
Unclaimed
E.R.C.P. CATHETER
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
No 510(k) on file
S&G Biotech, Inc.
Unclaimed
EGIS Biliary Double Bare Stent (BDB080405)
No 510(k) on file
S&G Biotech, Inc.
Unclaimed
EGIS Biliary Single Bare Stent
No 510(k) on file
Merit Medical Systems, Inc.
Unclaimed
Elation Wireguided Balloon Dilation Catheter
K151925
C.R. Bard, Inc.
Unclaimed
ELIMINATOR BALLOON DILATOR
No 510(k) on file
E-Z-Em, Inc.
Unclaimed
ENDODYNAMICS SIEGEL THERAPUTIC STENT
K853666
Softac Medical Technologies
Unclaimed
EndoFixTissue Fixation System
No 510(k) on file
Medi-Globe GmbH
Unclaimed
Endoflux Biliary & Pancreatic Stent Sets
No 510(k) on file
Endogi Medical, Ltd.
Unclaimed
EndoGI Biliary Stent System
No 510(k) on file
Endo GI Medical
Unclaimed
EndoGI S-Path Biliary Stent System
No 510(k) on file
Endogi Medical, Ltd.
Unclaimed
EndoGI S-Path Biliary Stent System
No 510(k) on file
Endo GI Medical
Unclaimed
EndoGI S-Path Biliary Stent System
No 510(k) on file
Endovations
Unclaimed
ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
No 510(k) on file
Endovations
Unclaimed
ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
No 510(k) on file
Cook Incorporated
Unclaimed
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
No 510(k) on file
Cook, Inc.
Unclaimed
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
No 510(k) on file
Boston Scientific Corporation
Unclaimed
Epic Biliary Endoscopic Stent System
No 510(k) on file
Everest Medical Corp.
Unclaimed
ERCP CANNULA
No 510(k) on file
United States Endoscopy Group, Inc.
Unclaimed
ERCP CANNULA
K924107
Cook Ireland, Ltd.
Unclaimed
EVOLUTION BILIARY STENT SYSTEM
No 510(k) on file
Navilyst Medical, Inc.
Unclaimed
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
No 510(k) on file
Schneider Intl., Ltd.
Unclaimed
EXPANDABLE BILIARY STENT ENDOPROSTHESIS
No 510(k) on file
Medi-Globe Corp.
Unclaimed
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
No 510(k) on file
Boston Scientific Corp
Unclaimed
EXPEL APD DRAINAGE CATHETER SYSTEM
No 510(k) on file
Boston Scientific Corporation
Unclaimed
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
No 510(k) on file
Boston Scientific
Unclaimed
Express SD Biliary Monorail Premounted Stent System
No 510(k) on file
Boston Scientific Corporation
Unclaimed
Express SD Biliary Monorail Premounted Stent System
No 510(k) on file
Boston Scientific Corp
Unclaimed
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
No 510(k) on file
Boston Scientific Corp
Unclaimed
EXTRACTOR RX RETRIEVAL BALLOON
No 510(k) on file
Boston Scientific Corp
Unclaimed
EXTRACTORRX
No 510(k) on file
Cook, Inc.
Unclaimed
FANELLI BILIARY STENT
K010601
Boston Scientific Corp
Unclaimed
FLEXIMA
No 510(k) on file
Boston Scientific/Medi-Tech
Unclaimed
FLEXIMA BILIARY CATHETER
K023870
Flexible Stenting Solutions, Inc.
Unclaimed
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
No 510(k) on file
Flexible Stenting Solutions, Inc.
Unclaimed
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
K102519
Cordis Corp.
Unclaimed
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
No 510(k) on file
Flexible Stenting Solutions, Inc.
Unclaimed
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Flexible Stenting Solutions, Inc.
Unclaimed
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Flexible Stenting Solutions, Inc.
Unclaimed
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K112522
Cook, Inc.
Unclaimed
FORMULA 418 BILIARY STENT
No 510(k) on file
Houston Biomedical, Inc.
Unclaimed
GASTROTOPO
No 510(k) on file
Gi Supply
Unclaimed
GI SUPPLY BILIARY STENT
No 510(k) on file
Cook, Inc.
Unclaimed
GIANTURCO-ROSCH BILIARY Z STENT
No 510(k) on file
Medi-Globe Corp.
Unclaimed
GIP/MEDI-GLOBE ERCP CATHETERS
No 510(k) on file
Medi-Globe Corp.
Unclaimed
GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
No 510(k) on file
Cook Incorporated
Unclaimed
Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
No 510(k) on file
W.L. Gore & Associates, Inc. Medical Products Div.
Unclaimed
GORE VIABIL BILILARY ENDOPROSTHESIS
No 510(k) on file
W. L. Gore & Associates, Inc.
Unclaimed
GORE VIABIL Short Wire Biliary Endoprosthesis
No 510(k) on file
Uresil, LLC
Unclaimed
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
K053245
Uresil Corp.
Unclaimed
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
No 510(k) on file
Cook, Inc.
Unclaimed
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
No 510(k) on file
Guidant Corp.
Unclaimed
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
No 510(k) on file
Guidant Corp.
Unclaimed
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
No 510(k) on file
Gyrus Acmi, Inc.
Unclaimed
Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
No 510(k) on file
Olympus Surgical Technologies America
Unclaimed
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
No 510(k) on file
M.I.Tech Co., Ltd.
Unclaimed
HANAROSTENT Benefit Biliary (NNN)
No 510(k) on file
M.I.Tech Co., Ltd.
Unclaimed
HANAROSTENT BILIARY (NNN)
K111149
M.I.Tech Co., Ltd.
Unclaimed
HANAROSTENT FASTTM Biliary (NNN)
No 510(k) on file
Horizons Intl. Corp.
Unclaimed
HORIZONS ERCP CANNULA
No 510(k) on file
Boston Scientific Corp
Unclaimed
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
No 510(k) on file
Innerdyne, Inc.
Unclaimed
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
No 510(k) on file
Interventional Thermodynamics, Inc.
Unclaimed
INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.
No 510(k) on file
Instent, Inc.
Unclaimed
INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
No 510(k) on file
Instent, Inc.
Unclaimed
INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
No 510(k) on file
Interventional Therapeutics Corp.
Unclaimed
INTHERM RADIALLY EXPANDING DILATER
No 510(k) on file
Interventional Therapeutics Corp.
Unclaimed
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
No 510(k) on file
Interventional Therapeutics Corp.
Unclaimed
INTHERM STASIS VALVE SYSTEM
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT LD
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT PARAMOUNT
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
K003450
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT DOUBLESTRUT XS STENT
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT II
No 510(k) on file
Sulzer Intratherapeutics, Inc.
Unclaimed
INTRASTENT LD (LARGE DIAMETER) STENT
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K003040
Intratherapeutics, Inc.
Unclaimed
ITI STENT
No 510(k) on file
Jomed AG
Unclaimed
JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
No 510(k) on file
Perry, Div.
Unclaimed
KELLY CHOLANGIOCATH
K833920
Akron Catheter, Inc.
Unclaimed
KELLY INFLATABLE T DRAIN
No 510(k) on file
Laparomed Corp.
Unclaimed
LAPAROMED CHOLANGIOGRAM DEVICE
No 510(k) on file
Baxter Healthcare Corp
Unclaimed
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
No 510(k) on file
Arrow Intl., Inc.
Unclaimed
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
No 510(k) on file
Orbus Medical Technologies
Unclaimed
LIFESTENT BILIARY ENDOPROSTHESIS
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404
Orbus Medical Technologies
Unclaimed
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Orbus Medical Technologies
Unclaimed
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985
Orbus Medical Technologies
Unclaimed
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Orbus Medical Technologies
Unclaimed
LIFESTENT SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Orbus Medical Technologies
Unclaimed
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
LIFESTENT TURBO BILIARY STENT SYSTEM
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
LIFESTENT TURBO BILIARY STENT SYSTEMS
No 510(k) on file
Hobbs Medical, Inc.
Unclaimed
LINDEN STONE EXTRACTION BALLOON
No 510(k) on file
Lucas Medical, Inc.
Unclaimed
LMI BILIARY CATHETER
No 510(k) on file
Cordis Corp.
Unclaimed
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
No 510(k) on file
C.R. Bard, Inc.
Unclaimed
LUMINEXX ENDOSCOPIC BILIARY STENT
No 510(k) on file
Meadox Surgimed, Inc.
Unclaimed
LUNDERQUIST - RING PTC DRAINAGE CATHETER
No 510(k) on file
Medical Device Technologies, Inc.
Unclaimed
MANAN BILIARY DRAINAGE CATHETER
No 510(k) on file
Manan Medical Products, Inc.
Unclaimed
MANAN BILIARY DRAINAGE CATHETER
No 510(k) on file
Manan Medical Products, Inc.
Unclaimed
MANAN INTRODUCER SHEALTH/NEEDLE
No 510(k) on file
Manan Medical Products, Inc.
Unclaimed
MANAN V.S. ACCESS NEEDLE/SET
No 510(k) on file
Medical Device Technologies, Inc.
Unclaimed
MANAN VS ACCESS NEEDLE/SET
No 510(k) on file
Medical Device Technologies, Inc.
Unclaimed
MANAN(TM) INTRODUCER SHEATH/NEEDLE
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
MARATHON STENT WITH FUSION TECHNOLOGY
No 510(k) on file
Boston Scientific Corp
Unclaimed
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
No 510(k) on file
Cook, Inc.
Unclaimed
MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
No 510(k) on file
Medinol, Ltd.
Unclaimed
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE STENT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE STENT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE STENT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC AVE BRIDGE X3 STENT
No 510(k) on file
Peripheral Ave
Unclaimed
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
No 510(k) on file
Boston Scientific Corp
Unclaimed
MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
No 510(k) on file
Boston Scientific Corp
Unclaimed
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
No 510(k) on file
Cordis Corp.
Unclaimed
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Solos Endoscopy, Inc.
Unclaimed
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
No 510(k) on file
Boston Scientific Corp
Unclaimed
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
No 510(k) on file
Medtronic Ave, Inc.
Unclaimed
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
No 510(k) on file
Cook, Inc.
Unclaimed
MODIFICATION TO COOK ZILVER BILIARY STENT
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
No 510(k) on file
Intratherapeutics, Inc.
Unclaimed
MODIFICATION TO INTRASTENT
No 510(k) on file
Orbus Medical Technologies
Unclaimed
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
No 510(k) on file
Guidant Corporation
Unclaimed
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134
Cordis Corp.
Unclaimed
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
No 510(k) on file
Sulzer Intratherapeutics, Inc.
Unclaimed
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K023243
Guidant Corp.
Unclaimed
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
K993588
Abbott Vascular, Inc.
Unclaimed
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336
Cordis Corp.
Unclaimed
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969
Cordis Corp.
Unclaimed
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Cook, Inc.
Unclaimed
MODIFICATION TO ZILVER 635 BILIARY STENT
No 510(k) on file
Telemed Systems, Inc.
Unclaimed
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
No 510(k) on file
Edwards Lifesciences, LLC
Unclaimed
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
No 510(k) on file
Abbott Vascular Devices
Unclaimed
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
No 510(k) on file
Cook, Inc.
Unclaimed
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481
Abbott Vascular, Inc.
Unclaimed
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
No 510(k) on file
Cook, Inc.
Unclaimed
MODIFICATION TO:ZILVER 518 BILIARY STENT
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
No 510(k) on file
Cook, Inc.
Unclaimed
MODIFIED COPE SUTURE ANCHOR
No 510(k) on file
Boston Scientific Corp
Unclaimed
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
K973113
Meadox Surgimed, Inc.
Unclaimed
MS CLASSIQUE BALLOON CATHETER
No 510(k) on file
Meadox Medicals, Div. Boston Scientific Corp.
Unclaimed
MS CLASSIQUE BALLOON DILATATION CAHTETER
No 510(k) on file
Navilyst Medical, Inc.
Unclaimed
MULTIPURPOSE DRAINAGE CATHETER
No 510(k) on file
Navilyst Medical, Inc.
Unclaimed
MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
No 510(k) on file
Navilyst Medical, Inc.
Unclaimed
MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
K093392
Dongguan TT Medical, Inc.
Unclaimed
MultiStage Balloon Dilatation Catheter
No 510(k) on file
Boston Scientific Corporation
Unclaimed
MUSTANG BALLOON DIALATION CATHETER
No 510(k) on file
Boston Scientific
Unclaimed
MUSTANG BALLOON DILATAION CATHETERS
No 510(k) on file
North American Instrument Corp.
Unclaimed
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
No 510(k) on file
Cook Ireland
Unclaimed
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Nasal Pancreatic Drainage Set
No 510(k) on file
Navarre Biomedical , Ltd.
Unclaimed
NAVARRE PERCUTANEOUS BILIARY DRAINAGE
K955110
Medinol, Ltd.
Unclaimed
NIR BILIARY STENT
K973171
Medinol, Ltd.
Unclaimed
NIR BILIARY STENT
No 510(k) on file
Boston Scientific Corp
Unclaimed
NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
No 510(k) on file
Boston Scientific Corp
Unclaimed
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
No 510(k) on file
Taewoong Medical Co., Ltd.
Unclaimed
Niti-S Biliary Slim M Stent
No 510(k) on file
Taewoong Medical Co., Ltd.
Unclaimed
Niti-S Biliary Speed D Stent
No 510(k) on file
Taewoong Medical Co., Ltd.
Unclaimed
NITI-S BILIARY STENT
K073667
Taewoong Medical Co., Ltd.
Unclaimed
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
K251123
Wilson-Cook Medical, Inc.
Unclaimed
OASIS BILIARY STENT INTRODUCTION SYSTEM
No 510(k) on file
Meadox Surgimed, Inc.
Unclaimed
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
No 510(k) on file
Olympus America, Inc.
Unclaimed
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
No 510(k) on file
Olympus America, Inc.
Unclaimed
OLYMPUS NBD TUBES
No 510(k) on file
Olympus Corp.
Unclaimed
OLYMPUS PBD STENTS
No 510(k) on file
Guidant Corp.
Unclaimed
OMNILINK .018 BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
OMNILINK .018 BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
OMNILINK .035 BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corporation
Unclaimed
OMNILINK .035 BILIARY STENT SYSTEM
No 510(k) on file
Guidant Endovascular Solutions, Inc.
Unclaimed
OMNILINK. 018 BILIARY STENT SYSTEM
No 510(k) on file
Applied Vascular Devices, Inc.
Unclaimed
OPERATIVE CHOLANGIOGRAPHIC CATHETER
No 510(k) on file
Cordis Corp.
Unclaimed
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
No 510(k) on file
Advanced Cardiovascular Systems, Inc.
Unclaimed
OTW MEGALINK SDS BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
No 510(k) on file
Cordis Corp.
Unclaimed
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
No 510(k) on file
Cordis Corp.
Unclaimed
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
PALMAZ XL TANSHEPATIC BILIARY STENTS
No 510(k) on file
Johnson & Johnson Interventional Systems
Unclaimed
PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
No 510(k) on file
Aomori Olympus Co., Ltd.
Unclaimed
PANCREATIC DRAINAGE TUBE
No 510(k) on file
Ev3, Inc.
Unclaimed
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
No 510(k) on file
Medical Device Technologies, Inc.
Unclaimed
PBN DILATORS
K990808
Interventional Therapeutics Corp.
Unclaimed
PERCUTANEOUS DILATOR WITH SHEATH
K913932
Cordis Corp.
Unclaimed
PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
No 510(k) on file
Peripheral Ave
Unclaimed
PERIPHERAL AVE STENT SYSTEM
K983008
American Endoscopy, Inc.
Unclaimed
PIGTAIL NASAL CATHETERS
No 510(k) on file
American Endoscopy, Inc.
Unclaimed
PIGTAIL STENTS
No 510(k) on file
Porges Corp.
Unclaimed
PORGES 2-WAY BALLOON EXTRACTION CATHETER
No 510(k) on file
Porges Corp.
Unclaimed
PORGES BILIARY STENTS
No 510(k) on file
Porges Corp.
Unclaimed
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
No 510(k) on file
Porges Corp.
Unclaimed
PORGES ERCP CATHETERS
No 510(k) on file
Porges Corp.
Unclaimed
PORGES NASOBILIARY DRAIN
No 510(k) on file
Olympus Corp.
Unclaimed
PR CANNULAS
No 510(k) on file
Cordis Corp.
Unclaimed
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Cordis Corporation
Unclaimed
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
PRIMUS GPS BILIARY STENT SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
PRIMUS STENT AND DELIVERY SYSTEM
K043243
Conmedcorp
Unclaimed
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
No 510(k) on file
Ev3, Inc.
Unclaimed
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
No 510(k) on file
Ev3 Corporation
Unclaimed
PROTEGE GPS SELF-EXPANDING NITINOL STENT
No 510(k) on file
Ev3, Inc.
Unclaimed
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
No 510(k) on file
Ev3, Inc.
Unclaimed
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314
Ev3 Corporation
Unclaimed
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
No 510(k) on file
Sulzer Intratherapeutics, Inc.
Unclaimed
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
No 510(k) on file
Sulzer Intratherapeutics, Inc.
Unclaimed
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
No 510(k) on file
Sulzer Intratherapeutics, Inc.
Unclaimed
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
PVL-4.8-200 BALLOON STONE EXTRACTOR
K851954
Wilson-Cook Medical, Inc.
Unclaimed
Quantum TTC Biliary Balloon Dilator
No 510(k) on file
Orbus Medical Technologies
Unclaimed
R STENT BILIARY ENDOPROSTHESIS
No 510(k) on file
Micro-Tech (Nanjing) Co., Ltd.
Unclaimed
Reliant Multistage Dilatation Balloon Catheter
No 510(k) on file
Micro-Tech (Nanjing) Co., Ltd.
Unclaimed
Reliant(TM) Multistage Dilatation Balloon Catheter
No 510(k) on file
Merit Medical Systems, Inc.
Unclaimed
RESOLVE BILIARY DRAINAGE CATHETER
K063733
Merit Medical Systems, Inc.
Unclaimed
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
K141408
Merit Medical Systems, Inc.
Unclaimed
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
No 510(k) on file
Rusch Intl.
Unclaimed
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Advanced Cardiovascular Systems, Inc.
Unclaimed
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
No 510(k) on file
Guidant Corp.
Unclaimed
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
No 510(k) on file
Guidant Corporation
Unclaimed
RX HERCULINK ELITE BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
RX HERCULINK PLUS BILIARY STENT SYSTEM
No 510(k) on file
Guidant Corp.
Unclaimed
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365
Cordis Corp.
Unclaimed
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646
Cordis Corp.
Unclaimed
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K994068
Cordis Corp.
Unclaimed
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Schneider Stent
Unclaimed
SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
K896163
Pfizer Hospital Products Group, Inc.
Unclaimed
SCHNEIDER WALLSTENT(R)
No 510(k) on file
Invatec S.P.A.
Unclaimed
SCUBA BILIARY STENT SYSTEM
No 510(k) on file
Abbott Laboratories
Unclaimed
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
K033537
Boston Scientific Corp
Unclaimed
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
No 510(k) on file
Boston Scientific Corp
Unclaimed
SENTINOL NITINOL BILLARY STENT SYSTEM
No 510(k) on file
Endovations
Unclaimed
SHEATH, ENDOSCOPE
K862059
Specialty Surgical Products, Inc.
Unclaimed
SILICONE BILIARY STENT/BILIARY CATHETER
No 510(k) on file
Aomori Olympus Co., Ltd.
Unclaimed
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333
Olympus Winter & Ibe GmbH
Unclaimed
SINGLE USE BALLOON DILATOR MAXPASSTM
No 510(k) on file
Olympus Medical Systems Corp.
Unclaimed
Single Use Biliary Balloon Dilator
No 510(k) on file
Olympus Medical Systems Corporation
Unclaimed
SINGLE USE BILIARY DRAINAGE STENT V
No 510(k) on file
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Unclaimed
Single use stone retrieval balloons
No 510(k) on file
Leo Medical Co., Ltd.
Unclaimed
Single-use Balloon Dilatation Catheter
K241888
Angiotech
Unclaimed
SKATER BILIARY CATHETER
No 510(k) on file
Angiotech
Unclaimed
SKATER BILIARY CATHETER
No 510(k) on file
Cordis Corp.
Unclaimed
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
No 510(k) on file
Cordis Corp.
Unclaimed
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
No 510(k) on file
Cordis Corp.
Unclaimed
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
Soehendra Stent Retriever
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
SOEHENDRA STENT RETRIEVER
No 510(k) on file
Micro-Tech (Nanjing) Co., Ltd.
Unclaimed
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
No 510(k) on file
Medi-Globe Corp.
Unclaimed
STONE EXTRACTOR BALLOON CATHETER
K011261
Idev Technologies, Inc.
Unclaimed
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
No 510(k) on file
Idev Technologies, Inc.
Unclaimed
SUPERA VERITAS
No 510(k) on file
Idev Technologies, Inc.
Unclaimed
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K122546
Idev Technologies, Inc.
Unclaimed
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
No 510(k) on file
Idev Technologies, Inc.
Unclaimed
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Telemed Systems, Inc.
Unclaimed
SURE-FLEX ANASTOMOTIC BALLOON DILATOR
No 510(k) on file
Idev Technologies, Inc.
Unclaimed
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
No 510(k) on file
Surgitek Medical Engineering Corp.
Unclaimed
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
No 510(k) on file
Boston Scientific Corp
Unclaimed
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Telemed Systems, Inc.
Unclaimed
TELEMED ERCP CANNULA
No 510(k) on file
Asahi Intecc Co., Ltd.
Unclaimed
Tornus ES
K241801
Cathaid, Inc.
Unclaimed
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU
No 510(k) on file
Boston Scientific Corp
Unclaimed
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397
Boston Scientific Corp
Unclaimed
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909
Boston Scientific Corp
Unclaimed
ULTRAFLEX DIAMOND
No 510(k) on file
Universal Medical Instrument Corp.
Unclaimed
UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
No 510(k) on file
Uresil Corp.
Unclaimed
URESIL BILLIARY CATHETER
No 510(k) on file
Uresil Corp.
Unclaimed
URESIL FIXATION DEVICE
No 510(k) on file
Uresil Corp.
Unclaimed
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
No 510(k) on file
Uresil Corp.
Unclaimed
URESIL GUIDEWIRE
K972582
C.R. Bard, Inc.
Unclaimed
USCI ENDOPROSTHESIS
No 510(k) on file
Bentec Medical, Inc.
Unclaimed
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
No 510(k) on file
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Unclaimed
VedDilator ^TM (3-Stage Balloon Dilation Catheter)
No 510(k) on file
W. L. Gore & Associates, Inc.
Unclaimed
VIABIL BILIARY ENDOPROSTHESIS
No 510(k) on file
W. L. Gore & Associates, Inc.
Unclaimed
VIABIL BILIARY ENDOPROSTHESIS
K014215
Wilson-Cook Medical, Inc.
Unclaimed
VPDS-1 VENNES PANCREATIC DILATION SET
No 510(k) on file
Boston Scientific
Unclaimed
WallFlex Biliary PLUS RX Stent System
K242950
Boston Scientific Corporation
Unclaimed
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
No 510(k) on file
Boston Scientific Corp
Unclaimed
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
No 510(k) on file
Boston Scientific Corporation
Unclaimed
WallFlex Biliary RX Stent System
No 510(k) on file
Boston Scientific
Unclaimed
WALLFLEX BILIARY RX STENT SYSTEM
No 510(k) on file
Boston Scientific
Unclaimed
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
No 510(k) on file
Boston Scientific Corporation
Unclaimed
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
K112543
Boston Scientific Corporation
Unclaimed
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
No 510(k) on file
Boston Scientific Corp
Unclaimed
WALLSTENT BILIARY ENDOPROSTHESIS
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232
Schneider U.S. Stent Div.
Unclaimed
WALLSTENT BILIARY ENDOPROTHESES
No 510(k) on file
Boston Scientific Corp
Unclaimed
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
K152853
Boston Scientific Corp
Unclaimed
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752
Boston Scientific Scimed, Inc.
Unclaimed
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
No 510(k) on file
Boston Scientific Scimed, Inc.
Unclaimed
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
No 510(k) on file
Schneider U.S. Stent Div.
Unclaimed
WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY
K914277
Abbott Laboratories
Unclaimed
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
No 510(k) on file
Boston Scientific Corp
Unclaimed
WELLFLEX BILIARY RX STENT SYSTEM
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILOSN-COOK BILIARY DILATION BALLOON
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK ZILVER BILIARY STENT
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
K896069
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK PANCREATIC WEDGE STENT
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
WILSON-COOK SYRINGE HOLDERS
No 510(k) on file
Wiltek Medical, Inc.
Unclaimed
WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Wiltek Medical, Inc.
Unclaimed
WILTEK BILIARY STENT SET
K894871
Wiltek Medical, Inc.
Unclaimed
WILTEK E.R.C.P. CATHETER
K894867
Wiltek Medical, Inc.
Unclaimed
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Wiltek Medical, Inc.
Unclaimed
WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
No 510(k) on file
Abbott Vascular, Inc.
Unclaimed
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
No 510(k) on file
Medinol, Ltd.
Unclaimed
X-Suit NIR Biliary Metallic Stent
No 510(k) on file
Abbott Laboratories
Unclaimed
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
No 510(k) on file
Abbott Laboratories
Unclaimed
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
No 510(k) on file
Abbott Laboratories
Unclaimed
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
No 510(k) on file
Abbott Laboratories
Unclaimed
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
No 510(k) on file
Cook, Inc.
Unclaimed
ZILVER 518 BILIARY STENT
K033348
Cook, Inc.
Unclaimed
ZILVER 518 BILIARY STENT
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
K182980
Cook Ireland, Ltd.
Unclaimed
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Zilver 635 Biliary Stent
K163018
Cook, Inc.
Unclaimed
ZILVER 635 BILIARY STENT
No 510(k) on file
Cook, Inc.
Unclaimed
ZILVER 635 BILIARY STENT
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
ZILVER BILIARY STENT SYSTEM USW
No 510(k) on file
Wilson-Cook Medical, Inc.
Unclaimed
ZIMMON BILIARY STENT SET
K851962
Wilson-Cook Medical, Inc.
Unclaimed
ZIMMON ENDOSCOPIC PANCREATIC STENT
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
No 510(k) on file
Cook Ireland, Ltd.
Unclaimed
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
No 510(k) on file