Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA product code DSY · 185 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.3450
Review panel: CV
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 2026-04-27

DSY 1996-03-11

DIASTAT VASCULAR ACCESS GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K955532

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DSY 1996-03-07

VASCUTEK GRAFT SIZER SET

Applicant Carbomedics, Inc.

K number K955588

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DSY 1996-02-09

VASCUTEK GELSOFT PLUS VASCULAR GRAFT

Applicant Vascutek, Ltd.

K number K955230

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DSY 1995-12-19

VASCUTEK GELWEAVE VASCULAR GRAFT

Applicant Vascutek, Ltd.

K number K952293

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DSY 1995-12-07

BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)

Applicant C.R. Bard, Inc.

K number K954582

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DSY 1995-10-06

DIASTAT VASCULAR ACCESS GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K953288

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DSY 1995-01-05

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS

Applicant Baxter Edwards

K number K944858

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DSY 1994-07-20

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

Applicant W. L. Gore & Associates, Inc.

K number K941981

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DSY 1994-06-02

BARD(R) EXPANDED PTFE VASCULAR GRAFT

Applicant C.R. Bard, Inc.

K number K940816

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DSY 1994-05-17

AOR-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K933987

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DSY 1994-05-02

DIASTAT VASCULAR ACCESS GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K940062

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DSY 1994-01-26

BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT

Applicant Baxter Healthcare Corp

K number K933590

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DSY 1993-12-08

FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS

Applicant W. L. Gore & Associates, Inc.

K number K933943

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DSY 1993-10-27

BARD PTFE VASCULAR GRAFT

Applicant C.R. Bard, Inc.

K number K933204

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DSY 1993-05-27

ATRIUM'S HYBRID PTFE

Applicant Atrium Medical Corp.

K number K925123

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DSY 1992-11-24

FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K922905

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DSY 1992-09-22

ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF

Applicant Pioneering Technologies, Inc.

K number K922025

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DSY 1991-11-27

PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION

Applicant Medtronic Vascular

K number K914116

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DSY 1991-11-05

GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

Applicant W. L. Gore & Associates, Inc.

K number K914447

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DSY 1991-10-23

OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

Applicant Intervascular, Inc.

K number K913143

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DSY 1991-09-23

LOW POROSITY (LP) VASCULAR PROSTHESIS

Applicant Intervascular, Inc.

K number K912911

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DSY 1991-04-02

OCHSNER 500 VASCULAR PROSTHESIS

Applicant Intervascular, Inc.

K number K905269

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DSY 1991-04-01

VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS

Applicant Vascutek, Ltd.

K number K910866

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DSY 1991-04-01

TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS

Applicant Vascutek, Ltd.

K number K910865

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DSY 1991-04-01

EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS

Applicant Vascutek, Ltd.

K number K910864

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DSY 1991-04-01

EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS

Applicant Vascutek, Ltd.

K number K910863

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DSY 1991-03-18

PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT

Applicant Pioneering Technologies, Inc.

K number K905067

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DSY 1991-02-15

OCHSNER 50 VASCULAR PROSTHESIS

Applicant Intervascular, Inc.

K number K905270

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DSY 1991-01-16

BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K904282

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DSY 1990-12-06

GORE-TEX(R) STRETCH VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K903931

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DSY 1990-12-03

OCHSNER 50 BIFURCATION

Applicant Intervascular, Inc.

K number K903964

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DSY 1990-09-05

AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K901641

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DSY 1990-07-03

PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS

Applicant Pioneering Technologies, Inc.

K number K901682

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DSY 1990-06-21

PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.

Applicant Medtronic Vascular

K number K896964

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DSY 1990-02-28

PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV

Applicant Aesculap Instruments Corp.

K number K890182

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DSY 1989-10-12

VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)

Applicant Medtronic Vascular

K number K894732

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DSY 1989-09-26

EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS

Applicant D-R Medical Systems, Inc.

K number K890597

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DSY 1989-09-20

PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)

Applicant Medtronic Vascular

K number K893459

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DSY 1989-01-12

TORAY VASCULAR PROSTHESIS

Applicant Toray Industries (America), Inc.

K number K884083

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DSY 1988-12-12

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.

Applicant Aries Medical, Inc.

K number K882289

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DSY 1988-08-04

CORONARY VEIN GRAFT MARKER

Applicant Med-Edge, Inc.

K number K882314

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DSY 1988-06-10

VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT

Applicant D-R Medical Systems, Inc.

K number K880041

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DSY 1988-06-09

VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT

Applicant D-R Medical Systems, Inc.

K number K880040

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DSY 1988-05-26

MEADOX INTRA-AORTIC GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K881283

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DSY 1988-05-18

GORE-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K880167

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DSY 1988-02-05

RADIALLY-SUPPORTED VASCULAR PROSTHESES

Applicant Intervascular, Inc.

K number K870884

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DSY 1987-08-27

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER

Applicant Edward Weck, Inc.

K number K871110

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DSY 1986-12-05

AVTECH LWP(LOW POROSITY) MWP(MEDIUM POROSITY)

Applicant Advanced Vascular Technologies, Inc.

K number K862697

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DSY 1986-09-15

VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN

Applicant Cobe Laboratories, Inc.

K number K861808

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DSY 1986-08-21

INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES

Applicant Intervascular, Inc.

K number K862739

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DSY 1986-08-18

INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR

Applicant Intervascular, Inc.

K number K854845

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DSY 1986-05-08

MEADOS INTRAORTIC GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K841596

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DSY 1986-05-07

MEADOX MEDICALS INC. GRAFT SIZER

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K854431

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DSY 1986-02-24

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES

Applicant Cobe Laboratories, Inc.

K number K853101

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DSY 1985-12-09

ATRIUM PLASMA TFE SYNTHETIC ARTERY

Applicant Atrium Medical Corp.

K number K853725

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DSY 1984-10-16

TETRAFLEX INTEGRALLY SUPPORTED PTFE

Applicant Shiley, Inc.

K number K831822

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DSY 1984-01-10

LP200 & HP800 SERIES VASCULAR PROSTH

Applicant Intervascular, Inc.

K number K833716

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DSY 1983-12-21

VASCUTEK VASCULAR PROTHESIS VP1200K/50K

Applicant Pacesetter Systems

K number K830016

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DSY 1983-10-19

IONESCU-SHILEY LOW POROSITY AORTIC GRAFT

Applicant Shiley, Inc.

K number K831880

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DSY 1983-10-19

IONESCU-SHILEY LOW POROSITY COMPOSITE

Applicant Shiley, Inc.

K number K831865

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DSY 1983-09-29

CORONARY ANASTOMOSIS MARKING SYSTEM

Applicant Biotrac Laboratories

K number K832806

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DSY 1983-07-19

VASCULAR GRAFT PROSTHESIS EXPANDED MICR

Applicant Impra, Inc.

K number K830543

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DSY 1983-07-12

MICROVEL DOUBLE VELOUR SUPPORTED 100

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K822633

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DSY 1982-08-31

BARD PTFE VASCULAR PROSTHESIS

Applicant C.R. Bard, Inc.

K number K821716

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DSY 1982-07-09

MEADOX WOVEN DOUBLE VELOUR

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K820696

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DSY 1982-07-08

HANCOCK VASCULAR GRAFT

Applicant Extracorporeal Medical Specialities, Inc.

K number K820600

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DSY 1982-05-18

FED RINGED-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K821158

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DSY 1981-11-24

COOLEY 2 VASCULAR PROSTHESIS STRAIGHT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K812248

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DSY 1981-09-16

MANUFACTURING PROCESS CHANGE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K811441

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DSY 1981-08-20

GORE-TEX VASULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K811510

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DSY 1981-05-08

DOUBLE VELOUR GRAFTS

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K810845

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DSY 1981-03-05

MEADOX SZILAGYI GRAFT

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K810376

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DSY 1981-02-02

IONESCU-SHILEY AORTIC GRAFT VALVE

Applicant Shiley, Inc.

K number K803000

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DSY 1980-10-10

GORE-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K number K802095

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DSY 1980-09-09

VASCULAR GRAFT PROSTH. OF EXP. MICRO.

Applicant Impra, Inc.

K number K801621

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DSY 1980-05-23

USCI INTRALUMINAL GRAFT W/DACRON TIE

Applicant C.R. Bard, Inc.

K number K801156

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DSY 1980-02-28

USCI SAUVAGE EXS VASCULAR PROSTHESIS

Applicant C.R. Bard, Inc.

K number K800149

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DSY 1979-09-27

BJORK-SHILEY PULMONIC GRAFT VALVE

Applicant Shiley, Inc.

K number K791828

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DSY 1977-10-21

CABG RINGS

Applicant A&A Ent.

K number K771819

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DSY 1977-02-25

SAUVAGE FILAMENTOUS PROSTHESES

Applicant Usci, Div. C.R. Bard, Inc.

K number K770236

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DSY 1977-02-24

DEBAKEY VASCULOUR-D PROSTHESES

Applicant Usci, Div. C.R. Bard, Inc.

K number K770235

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DSY 1976-07-20

PROSTHESIS, VASCULAR BIFURCATED

Applicant Usci, Div. C.R. Bard, Inc.

K number K760130

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DSY 1976-07-20

GRAFT, COOLEY WOVEN VASCULAR, STERILE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K760092

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DSY 1976-07-20

GRAFT, MICROVEL GUIDELINE, STERILE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K760091

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DSY 1976-07-20

GRAFT, COOLEY GUIDELINE, STERILE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K760090

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