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., Atrium Medical Corp. and Meadox Medicals, Div. Boston Scientific Corp..

188
Total
186
Cleared
114d
Avg days
1976
Since
188 devices
25–48 of 188
Cleared Mar 30, 2006
ATRIUM FLIXENE GRAFT
K060124
Atrium Medical Corp.
Cardiovascular · 71d
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 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 Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900
Edwards Lifesciences, LLC
Cardiovascular · 78d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767
Atrium Medical Corp.
Cardiovascular · 26d
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 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 01, 2000
ADVANTA SUPER SOFT GRAFT
K000499
Atrium Medical Corp.
Cardiovascular · 15d
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 Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 6S GRAFT,MODEL 31453, 6T GRAFT,MODEL 31452
K984182
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Jul 21, 1997
UNI-GRAFT K DV
K963790
Atrium Medical Corp.
Cardiovascular · 304d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 266d
Cleared Jan 22, 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 254d
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 Mar 11, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955532
W.L. Gore & Associates, Inc.
Cardiovascular · 97d
Cleared Dec 07, 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582
C.R. Bard, Inc.
Cardiovascular · 91d