ClearanceBrief
Panels › Cardiovascular › Product code DSY · Class 2

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Regulation 870.3450

1510(k)s in 12 months (188 all time)
2recalls in 12 months (87 all time)
86recalls that name a 510(k)
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Top companies in DSY

Decided510(k)Device and applicantCode
Jun 19, 1996K961134BARD GRAFT SIZER
C.R. Bard, Inc.
DSY
May 30, 1996K955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
Meadox Medicals, Div. Boston Scientific Corp.
DSY
Apr 25, 1996K960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
Carbomedics, Inc.
DSY
Mar 11, 1996K955532DIASTAT VASCULAR ACCESS GRAFT
W. L. Gore & Associates, Inc.
DSY
Mar 7, 1996K955588VASCUTEK GRAFT SIZER SET
Carbomedics, Inc.
DSY
Feb 9, 1996K955230VASCUTEK GELSOFT PLUS VASCULAR GRAFT
Vascutek, Ltd.
DSY
Dec 19, 1995K952293VASCUTEK GELWEAVE VASCULAR GRAFT
Vascutek, Ltd.
DSY
Dec 7, 1995K954582BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
C.R. Bard, Inc.
DSY
Oct 6, 1995K953288DIASTAT VASCULAR ACCESS GRAFT
W. L. Gore & Associates, Inc.
DSY
Jan 5, 1995K944858BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
Baxter Edwards
DSY
Jul 20, 1994K941981AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
W. L. Gore & Associates, Inc.
DSY
Jun 2, 1994K940816BARD(R) EXPANDED PTFE VASCULAR GRAFT
C.R. Bard, Inc.
DSY
May 17, 1994K933987AOR-TEX VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
May 2, 1994K940062DIASTAT VASCULAR ACCESS GRAFT
W. L. Gore & Associates, Inc.
DSY
Jan 26, 1994K933590BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
Baxter Healthcare Corp
DSY
Dec 8, 1993K933943FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
W. L. Gore & Associates, Inc.
DSY
Oct 27, 1993K933204BARD PTFE VASCULAR GRAFT
C.R. Bard, Inc.
DSY
May 27, 1993K925123ATRIUM'S HYBRID PTFE
Atrium Medical Corp.
DSY
Nov 24, 1992K922905FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
Sep 22, 1992K922025ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
Pioneering Technologies, Inc.
DSY
Nov 27, 1991K914116PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
Medtronic Vascular
DSY
Nov 5, 1991K914447GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
W. L. Gore & Associates, Inc.
DSY
Oct 23, 1991K913143OCHSNER ULP BIFURCATION VASCULAR PROTHESIS
Intervascular, Inc.
DSY
Sep 23, 1991K912911LOW POROSITY (LP) VASCULAR PROSTHESIS
Intervascular, Inc.
DSY
Apr 2, 1991K905269OCHSNER 500 VASCULAR PROSTHESIS
Intervascular, Inc.
DSY
Apr 1, 1991K910866VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
Vascutek, Ltd., GB
DSY
Apr 1, 1991K910865TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
Vascutek, Ltd., GB
DSY
Apr 1, 1991K910864EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
Vascutek, Ltd., GB
DSY
Apr 1, 1991K910863EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
Vascutek, Ltd., GB
DSY
Mar 18, 1991K905067PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
Pioneering Technologies, Inc.
DSY
Feb 15, 1991K905270OCHSNER 50 VASCULAR PROSTHESIS
Intervascular, Inc.
DSY
Jan 16, 1991K904282BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
Dec 6, 1990K903931GORE-TEX(R) STRETCH VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
Dec 3, 1990K903964OCHSNER 50 BIFURCATION
Intervascular, Inc.
DSY
Sep 5, 1990K901641AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
Jul 3, 1990K901682PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
Pioneering Technologies, Inc.
DSY
Jun 21, 1990K896964PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
Medtronic Vascular
DSY
Feb 28, 1990K890182PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
Aesculap Instruments Corp.
DSY
Oct 12, 1989K894732VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
Medtronic Vascular
DSY
Sep 26, 1989K890597EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
D-R Medical Systems, Inc.
DSY
Sep 20, 1989K893459PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
Medtronic Vascular
DSY
Jan 12, 1989K884083TORAY VASCULAR PROSTHESIS
Toray Industries (America), Inc.
DSY
Dec 12, 1988K882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.
Aries Medical, Inc.
DSY
Aug 4, 1988K882314CORONARY VEIN GRAFT MARKER
Med-Edge, Inc.
DSY
Jun 10, 1988K880041VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT
D-R Medical Systems, Inc.
DSY
Jun 9, 1988K880040VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT
D-R Medical Systems, Inc.
DSY
May 26, 1988K881283MEADOX INTRA-AORTIC GRAFT
Meadox Medicals, Div. Boston Scientific Corp.
DSY
May 18, 1988K880167GORE-TEX VASCULAR GRAFT
W. L. Gore & Associates, Inc.
DSY
Feb 5, 1988K870884RADIALLY-SUPPORTED VASCULAR PROSTHESES
Intervascular, Inc.
DSY
Aug 27, 1987K871110CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
Edward Weck, Inc.
DSY

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