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
49–72 of 188
Cleared Mar 30, 2006
ATRIUM FLIXENE GRAFT
K060124
Atrium Medical Corp.
Cardiovascular · 71d
Cleared Feb 07, 2006
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142
Vascutek, Ltd.
Cardiovascular · 19d
Cleared Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964
Boston Scientific Corp
Cardiovascular · 77d
Cleared Nov 04, 2005
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312
Veryan Medical Limited
Cardiovascular · 169d
Cleared Sep 29, 2005
ADVANTA T-GRAFT
K051332
Atrium Medical Corp.
Cardiovascular · 129d
Cleared Sep 20, 2005
VENAFLO II VASCULAR GRAFT
K052282
Bard Peripheral Vascular, Inc.
Cardiovascular · 29d
Cleared Jan 31, 2005
DYNAFLO BYPASS GRAFT
K050049
Bard Peripheral Vascular, Inc.
Cardiovascular · 21d
Cleared Jan 05, 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Sep 14, 2004
MODIFICATION TO EPTFE GRAFT
K041528
Vascutek, Ltd.
Cardiovascular · 98d
Cleared May 20, 2004
GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
K040829
Vascutek, Ltd.
Cardiovascular · 50d
Cleared Feb 19, 2004
GELSOFT PLUS ERS
K034010
Vascutek, Ltd.
Cardiovascular · 57d
Cleared Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900
Edwards Lifesciences, LLC
Cardiovascular · 78d
Cleared Apr 09, 2003
EPTFE VASCULAR PROSTHESIS
K030999
Vascutek, Ltd.
Cardiovascular · 9d
Cleared Jan 24, 2003
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K021547
Jotec GmbH
Cardiovascular · 259d
Cleared Aug 14, 2002
INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
K022242
Intervascular
Cardiovascular · 34d
Cleared Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K013022
Sulzer Carbomedics, Inc.
Cardiovascular · 279d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767
Atrium Medical Corp.
Cardiovascular · 26d
Cleared Feb 27, 2002
INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
K013651
Intervascular
Cardiovascular · 113d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577
Atrium Medical Corp.
Cardiovascular · 88d
Cleared Oct 26, 2001
GORE-TEX VASCULAR GRAFT
K013250
W.L. Gore & Associates, Inc.
Cardiovascular · 28d
Cleared Oct 02, 2001
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952
Boston Scientific/Medi-Tech
Cardiovascular · 28d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516
Atrium Medical Corp.
Cardiovascular · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517
Atrium Medical Corp.
Cardiovascular · 85d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011
Impra, Inc.
Cardiovascular · 90d