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
73–96 of 188
Cleared Jan 25, 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K002007
Sulzer Carbomedics, Inc.
Cardiovascular · 206d
Cleared Jan 08, 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
K990800
Intervascular, Inc.
Cardiovascular · 670d
Cleared Dec 18, 2000
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
K001927
Thoratec Laboratories Corp.
Cardiovascular · 175d
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000499
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667
Sulzermedica
Cardiovascular · 88d
Cleared Dec 09, 1999
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
K990503
Sulzermedica
Cardiovascular · 295d
Cleared Nov 19, 1999
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832
Sulzermedica
Cardiovascular · 88d
Cleared Oct 01, 1999
ADVANTA GRAFT (>6MM)
K992960
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992443
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Jul 09, 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602
W.L. Gore & Associates, Inc.
Cardiovascular · 60d
Cleared Jun 01, 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813
Atrium Medical Corp.
Cardiovascular · 5d
Cleared Apr 22, 1999
BI-DIRECTIONAL TUNNELER
K991027
Impra, Inc.
Cardiovascular · 24d
Cleared Feb 22, 1999
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K984294
Intervascular, Inc.
Cardiovascular · 83d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Nov 24, 1998
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
K983819
Intervascular, Inc.
Cardiovascular · 26d
Cleared Nov 24, 1998
DISTAFLO BYPASS GRAFT
K983861
Impra, Inc.
Cardiovascular · 22d
Cleared Nov 19, 1998
IMPRA HIGH POROSITY GRAFT
K983064
Impra, Inc.
Cardiovascular · 78d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079
Impra, Inc.
Cardiovascular · 44d
Cleared Jul 21, 1997
UNI-GRAFT K DV
K963790
Atrium Medical Corp.
Cardiovascular · 304d
Cleared Jun 05, 1997
INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K970843
Intervascular, Inc.
Cardiovascular · 90d
Cleared May 05, 1997
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
K964625
Intervascular, Inc.
Cardiovascular · 171d
Cleared Apr 15, 1997
IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
K971192
Impra, Inc.
Cardiovascular · 15d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 266d
Cleared Mar 10, 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959
Vascutek, Ltd.
Cardiovascular · 89d