W.L. Gore & Associates, Inc. - FDA 510(k) Cleared Devices

Cleared Feb 20, 1997

GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)

K964061 · LYK

Cardiovascular · 133d

Cleared May 23, 1996

PRECLUDE IMA SLEEVE

K960532 · MFX

Cardiovascular · 106d

Cleared May 15, 1996

DIASTAT VASCULAR ACCESS GRAFT

K955533 · DYF

Cardiovascular · 162d

Cleared Mar 11, 1996

DIASTAT VASCULAR ACCESS GRAFT

K955532 · DSY

Cardiovascular · 97d

Cleared Oct 06, 1995

DIASTAT VASCULAR ACCESS GRAFT

K953287 · DYF

Cardiovascular · 85d

Cleared Oct 06, 1995

DIASTAT VASCULAR ACCESS GRAFT

K953288 · DSY

Cardiovascular · 84d

Cleared Feb 22, 1995

CVPRO CARDIOVASCULAR PATCH

K943736 · DXZ

Cardiovascular · 204d

Not Cleared Jul 20, 1994

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

K941981 · DSY

Cardiovascular · 97d

Cleared May 18, 1994

GORE-TEX CARDIOVASCULAR PATCH

K940906 · DXZ

Cardiovascular · 83d

Cleared May 17, 1994

AOR-TEX VASCULAR GRAFT

K933987 · DSY

Cardiovascular · 273d

Not Cleared May 04, 1994

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

K940824 · DYF

Cardiovascular · 118d

Not Cleared May 02, 1994

DIASTAT VASCULAR ACCESS GRAFT

K940062 · DSY

Cardiovascular · 116d

Cleared Dec 08, 1993

FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS

K933943 · DSY

Cardiovascular · 114d

Cleared Dec 08, 1993

FEP RINGED GORE-TEX VASCULAR GRAFT

K934726 · DYF

Cardiovascular · 68d

Cleared Oct 22, 1993

GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE

K930950 · DXZ

Cardiovascular · 241d

Cleared Nov 24, 1992

FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT

K922905 · DSY

Cardiovascular · 161d

Cleared Jun 03, 1992

GORE TUNNELER, MODIFICATION

K920998 · DYB

Cardiovascular · 93d

Cleared Nov 05, 1991

GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

K914447 · DSY

Cardiovascular · 32d

Cleared Nov 05, 1991

GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE

K914448 · DXZ

Cardiovascular · 32d

Cleared Nov 05, 1991

GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE

K914450 · DXZ

Cardiovascular · 32d

Cleared Oct 11, 1991

GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM

K912107 · DXZ

Cardiovascular · 151d

Cleared Mar 26, 1991

GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE

K910464 · DXZ

Cardiovascular · 50d

Cleared Jan 16, 1991

BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

K904282 · DSY

Cardiovascular · 120d

Cleared Dec 06, 1990

GORE-TEX(R) STRETCH VASCULAR GRAFT

K903931 · DSY

Cardiovascular · 104d

Cleared Sep 05, 1990

AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

K901641 · DSY

Cardiovascular · 149d