Stents, Drains And Dilators For The Biliary Ducts

FDA product code FGE · 462 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5010
Review panel: GU
Implant: Yes
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1982-08-10 – 2026-09-18

FGE 1999-08-02

MEDTRONIC AVE BRIDGE STENT

Applicant Medtronic Ave, Inc.

K number K992318

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FGE 1999-08-02

INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE

Applicant Innerdyne, Inc.

K number K990854

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FGE 1999-07-29

MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION

Applicant Peripheral Ave

K number K991533

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FGE 1999-06-25

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM

Applicant AngioDynamics, Inc.

K number K991793

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FGE 1999-05-05

CYSTIC DUCT BALLOON DILATING CATHETER

Applicant Applied Medical Resources

K number K983154

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FGE 1999-04-30

GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58

Applicant Guidant Corp.

K number K991032

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FGE 1999-04-30

CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC

Applicant Cordis Corp.

K number K990631

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FGE 1999-03-03

GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38

Applicant Guidant Corp.

K number K983075

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FGE 1999-02-12

WILSON-COOK PANCREATIC WEDGE STENT

Applicant Wilson-Cook Medical, Inc.

K number K990130

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FGE 1999-01-29

ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM

Applicant AngioDynamics, Inc.

K number K982346

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FGE 1998-12-18

CORDIS NITINOL STENT AND DELIVERY SYSTEM

Applicant Cordis Corp.

K number K980823

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FGE 1998-11-25

PERIPHERAL AVE STENT SYSTEM

Applicant Peripheral Ave

K number K983008

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FGE 1998-11-13

NIR BILIARY STENT

Applicant Medinol, Ltd.

K number K973171

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FGE 1998-10-16

FLEXIMA

Applicant Boston Scientific Corp

K number K982508

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FGE 1998-09-02

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K982005

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FGE 1998-07-21

ITI STENT

Applicant Intratherapeutics, Inc.

K number K980290

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FGE 1998-06-09

PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM

Applicant Cordis Corp.

K number K980653

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FGE 1998-04-27

MANAN VS ACCESS NEEDLE/SET

Applicant Medical Device Technologies, Inc.

K number K980372

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FGE 1998-02-09

MANAN BILIARY DRAINAGE CATHETER

Applicant Medical Device Technologies, Inc.

K number K980191

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FGE 1998-01-09

MANAN(TM) INTRODUCER SHEATH/NEEDLE

Applicant Medical Device Technologies, Inc.

K number K974815

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FGE 1997-12-15

COURIER ST BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K973008

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FGE 1997-11-21

URESIL GUIDEWIRE

Applicant Uresil Corp.

K number K972582

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FGE 1997-11-10

MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM

Applicant Boston Scientific Corp

K number K973113

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FGE 1997-11-05

AVE BRIDGE STENT SYSTEM

Applicant Arterial Vascular Engineering, Inc.

K number K971295

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FGE 1997-10-07

OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB

Applicant Cordis Corp.

K number K972825

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FGE 1997-09-19

SILICONE BILIARY STENT/BILIARY CATHETER

Applicant Specialty Surgical Products, Inc.

K number K973114

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FGE 1997-08-29

URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S

Applicant Uresil Corp.

K number K972583

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FGE 1997-06-30

BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

Applicant Boston Scientific Corp

K number K965147

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FGE 1997-06-20

LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT

Applicant Cordis Corp.

K number K964688

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FGE 1997-05-21

SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

Applicant Boston Scientific Corp

K number K963254

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FGE 1997-05-20

ULTRAFLEX DIAMOND

Applicant Boston Scientific Corp

K number K962899

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FGE 1997-05-16

MANAN V.S. ACCESS NEEDLE/SET

Applicant Manan Medical Products, Inc.

K number K963767

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FGE 1997-05-02

BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS

Applicant C.R. Bard, Inc.

K number K963782

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FGE 1997-04-28

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K964119

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FGE 1997-03-25

EXTRACTORRX

Applicant Boston Scientific Corp

K number K970052

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FGE 1996-12-12

COURIER BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K963691

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FGE 1996-11-25

ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K963397

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FGE 1996-11-07

NAVARRE PERCUTANEOUS BILIARY DRAINAGE

Applicant Navarre Biomedical , Ltd.

K number K955110

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FGE 1996-10-25

OLYMPUS B-5/B-7 SERIESBALLOON CATHETER

Applicant Olympus America, Inc.

K number K962925

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FGE 1996-07-24

DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

Applicant Ideas For Medicine, Inc.

K number K954713

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FGE 1996-05-23

MANAN INTRODUCER SHEALTH/NEEDLE

Applicant Manan Medical Products, Inc.

K number K961216

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FGE 1996-05-10

WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS

Applicant Boston Scientific Scimed, Inc.

K number K961262

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FGE 1996-05-10

LMI BILIARY CATHETER

Applicant Lucas Medical, Inc.

K number K955126

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FGE 1996-05-08

CORDIS BILIARY STENT

Applicant Cordis Corp.

K number K955728

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FGE 1996-03-26

MANAN BILIARY DRAINAGE CATHETER

Applicant Manan Medical Products, Inc.

K number K954043

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FGE 1996-02-08

ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER

Applicant Endovations

K number K955413

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FGE 1995-10-07

MS CLASSIQUE BALLOON DILATATION CAHTETER

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K953332

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FGE 1995-09-12

INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS

Applicant Instent, Inc.

K number K945498

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FGE 1995-09-08

INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS

Applicant Instent, Inc.

K number K924387

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FGE 1995-09-01

GIP/MEDI-GLOBE ERCP CATHETERS

Applicant Medi-Globe Corp.

K number K953827

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FGE 1995-06-30

GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES

Applicant Medi-Globe Corp.

K number K941973

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FGE 1995-06-13

OLYMPUS NBD TUBES

Applicant Olympus America, Inc.

K number K944912

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FGE 1995-04-05

OLYMPUS PBD STENTS

Applicant Olympus Corp.

K number K933200

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FGE 1995-03-13

MS CLASSIQUE BALLOON CATHETER

Applicant Meadox Surgimed, Inc.

K number K944143

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FGE 1995-03-09

WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER

Applicant Wilson-Cook Medical, Inc.

K number K941350

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FGE 1995-02-28

BILIARY STENT

Applicant Menlo Care, Inc.

K number K943143

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FGE 1995-01-24

BALLOON DILATION CATHETER

Applicant Wilson-Cook Medical, Inc.

K number K935094

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FGE 1995-01-11

BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM

Applicant Schneider Intl., Ltd.

K number K925406

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FGE 1994-09-30

WALLSTENT BILIARY ENDOPROTHESES

Applicant Schneider U.S. Stent Div.

K number K923993

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FGE 1994-09-28

MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH

Applicant Boston Scientific Corp

K number K930623

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FGE 1994-08-17

AMERICAN CATHETER E.R.C.P. CANNULA

Applicant Intl. Medical, Inc.

K number K940370

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FGE 1994-05-20

ELIMINATOR BALLOON DILATOR

Applicant C.R. Bard, Inc.

K number K940965

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FGE 1994-02-07

INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.

Applicant Interventional Thermodynamics, Inc.

K number K934377

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FGE 1994-01-26

HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

Applicant Boston Scientific Corp

K number K924608

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FGE 1993-09-28

INTHERM STASIS VALVE SYSTEM

Applicant Interventional Therapeutics Corp.

K number K931025

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FGE 1993-07-13

URESIL BILLIARY CATHETER

Applicant Uresil Corp.

K number K923096

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FGE 1992-12-30

ERCP CANNULA

Applicant United States Endoscopy Group, Inc.

K number K924107

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FGE 1992-11-24

BARD BILIARY BALLOON DILATORS

Applicant C.R. Bard, Inc.

K number K920361

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FGE 1992-10-23

INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR

Applicant Interventional Therapeutics Corp.

K number K924451

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FGE 1992-07-02

MCLEAN-STOCK PERCUTANEOUS T-TUBE SET

Applicant Cook, Inc.

K number K921654

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FGE 1992-05-15

GIANTURCO-ROSCH BILIARY Z STENT

Applicant Cook, Inc.

K number K921191

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FGE 1992-05-06

CHOLANGIOGRAM CATHETER KIT

Applicant Mccol Medical,Inc.

K number K920236

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FGE 1992-03-11

ACKRAD ERCP CONTRAST DELIVERY SET

Applicant Ackrad Laboratories

K number K915813

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FGE 1992-02-19

URESIL FIXATION DEVICE

Applicant Uresil Corp.

K number K914699

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FGE 1992-01-30

E.R.C.P. CATHETER

Applicant Surgitek Medical Engineering Corp.

K number K914495

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FGE 1992-01-28

CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM

Applicant Medical Dynamics, Inc.

K number K913986

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FGE 1992-01-07

WILTEK BALLOON CHOLANGIOGRAPHY CATHETER

Applicant Wiltek Medical, Inc.

K number K914882

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FGE 1992-01-07

WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

Applicant Wiltek Medical, Inc.

K number K914881

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FGE 1991-11-29

WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY

Applicant Schneider U.S. Stent Div.

K number K914277

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FGE 1991-11-22

PERCUTANEOUS DILATOR WITH SHEATH

Applicant Interventional Therapeutics Corp.

K number K913932

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FGE 1991-10-25

DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT

Applicant Biosearch Medical Products, Inc.

K number K913073

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FGE 1991-10-08

2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH

Applicant Endovations

K number K913841

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FGE 1991-09-27

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON

Applicant Baxter Healthcare Corp

K number K911630

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FGE 1991-09-23

WILTEK STANDARD CHOLANGIOGRAPHY CATHETER

Applicant Wiltek Medical, Inc.

K number K912288

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FGE 1991-09-23

CHOLANGIOGRAPHY CATHETER

Applicant Wiltek Medical, Inc.

K number K912122

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FGE 1991-09-13

INTHERM RADIALLY EXPANDING DILATER

Applicant Interventional Therapeutics Corp.

K number K912971

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FGE 1991-08-20

DRAINAGE CATHETERS W/A DISSOLVABLE TIP

Applicant Boston Scientific Corp

K number K900205

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FGE 1991-06-04

PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION

Applicant Johnson & Johnson Interventional Systems

K number K911581

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FGE 1991-05-10

MODEL GS-4700 COMMON DUCT STONE REMOVING KIT

Applicant Solos Endoscopy, Inc.

K number K910671

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FGE 1991-05-01

SCHNEIDER WALLSTENT(R)

Applicant Pfizer Hospital Products Group, Inc.

K number K911292

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FGE 1991-04-08

LAPAROMED CHOLANGIOGRAM DEVICE

Applicant Laparomed Corp.

K number K910219

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FGE 1991-04-02

BILIARY BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K910931

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FGE 1991-03-28

AVD INTIMAX CHOLANGIOGRAPHY CATHETER

Applicant Applied Vascular Devices, Inc.

K number K910493

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FGE 1991-03-21

OPERATIVE CHOLANGIOGRAPHIC CATHETER

Applicant Applied Vascular Devices, Inc.

K number K905738

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FGE 1991-03-19

SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE

Applicant Surgitek Medical Engineering Corp.

K number K910768

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FGE 1991-03-15

BALLOON CATHETERS

Applicant Olympus Corp.

K number K904669

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FGE 1991-02-13

AVD INTIMAX (TM) BILIARY CATHETER

Applicant Applied Vascular

K number K910006

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FGE 1991-02-13

BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS

Applicant Baxter Healthcare Corp

K number K905707

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FGE 1991-02-01

ERCP CANNULA

Applicant Everest Medical Corp.

K number K905714

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FGE 1991-01-18

LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS

Applicant Arrow Intl., Inc.

K number K905229

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