DSY · Class II · 21 CFR 870.3450

FDA Product Code DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA product code DSY covers vascular graft prostheses with a diameter of 6mm or greater.

These synthetic conduits — typically made from Dacron (polyester) or ePTFE — replace or bypass diseased segments of the aorta, iliac, or femoral arteries in open vascular surgery. Large-diameter grafts are used in aortic aneurysm repair and aortoiliac occlusive disease.

DSY devices are Class II medical devices, regulated under 21 CFR 870.3450 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include W.L. Gore & Associates, Inc., Vascutek, Ltd. and Atrium Medical Corp..

188
Total
186
Cleared
114d
Avg days
1976
Since
188 devices
97–120 of 188
Cleared Feb 19, 1997
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)
K964665
Carbomedics, Inc.
Cardiovascular · 90d
Cleared Jan 22, 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 254d
Cleared Jan 02, 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197
Impra, Inc.
Cardiovascular · 73d
Cleared Oct 03, 1996
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K962639
Impra, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1996
BARD GRAFT SIZER
K961134
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared May 30, 1996
MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT
K955460
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 183d
Cleared Apr 25, 1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K960706
Carbomedics, Inc.
Cardiovascular · 64d
Cleared Mar 11, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Mar 07, 1996
VASCUTEK GRAFT SIZER SET
K955588
Carbomedics, Inc.
Cardiovascular · 91d
Cleared Feb 09, 1996
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230
Vascutek, Ltd.
Cardiovascular · 87d
Cleared Dec 19, 1995
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293
Vascutek, Ltd.
Cardiovascular · 217d
Cleared Dec 07, 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582
C.R. Bard, Inc.
Cardiovascular · 91d
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953288
W.L. Gore & Associates, Inc.
Cardiovascular · 84d
Cleared Jan 05, 1995
BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS
K944858
Baxter Edwards
Cardiovascular · 94d
Not Cleared Jul 20, 1994
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K941981
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Jun 02, 1994
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816
C.R. Bard, Inc.
Cardiovascular · 100d
Cleared May 17, 1994
AOR-TEX VASCULAR GRAFT
K933987
W.L. Gore & Associates, Inc.
Cardiovascular · 273d
Not Cleared May 02, 1994
DIASTAT VASCULAR ACCESS GRAFT
K940062
W.L. Gore & Associates, Inc.
Cardiovascular · 116d
Cleared Jan 26, 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590
Baxter Healthcare Corp
Cardiovascular · 184d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS
K933943
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Oct 27, 1993
BARD PTFE VASCULAR GRAFT
K933204
C.R. Bard, Inc.
Cardiovascular · 118d
Cleared May 27, 1993
ATRIUM'S HYBRID PTFE
K925123
Atrium Medical Corp.
Cardiovascular · 226d
Cleared Nov 24, 1992
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905
W.L. Gore & Associates, Inc.
Cardiovascular · 161d
Cleared Sep 22, 1992
ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
K922025
Pioneering Technologies, Inc.
Cardiovascular · 168d