DYF · Class II · 21 CFR 870.3450

FDA Product Code DYF: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Leading manufacturers include W.L. Gore & Associates, Inc., Atrium Medical Corp. and Baxter Healthcare Corp.

21
Total
20
Cleared
122d
Avg days
1979
Since

FDA 510(k) Cleared Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Devices (Product Code DYF)

21 devices
1–21 of 21
Cleared Mar 01, 2000
ADVANTA SUPER SOFT GRAFT
K000504
Atrium Medical Corp.
Cardiovascular · 15d
Cleared Oct 01, 1999
ADVANTA GRAFT (<6MM)
K992958
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Sep 08, 1999
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Aug 20, 1999
ADVANTA GRAFT
K992441
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Feb 01, 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183
Possis Medical, Inc.
Cardiovascular · 70d
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766
Meadox Medicals, Div. Boston Scientific Corp.
Cardiovascular · 387d
Cleared May 15, 1996
DIASTAT VASCULAR ACCESS GRAFT
K955533
W.L. Gore & Associates, Inc.
Cardiovascular · 162d
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953287
W.L. Gore & Associates, Inc.
Cardiovascular · 85d
Cleared Mar 31, 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844
Baxter Healthcare Corp
Cardiovascular · 182d
Cleared Dec 15, 1994
ATRIUM'S HYBRID PTFE
K933391
Atrium Medical Corp.
Cardiovascular · 521d
Not Cleared May 04, 1994
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824
W.L. Gore & Associates, Inc.
Cardiovascular · 118d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726
W.L. Gore & Associates, Inc.
Cardiovascular · 68d
Cleared May 18, 1988
GORE-TEX VASCULAR GRAFT
K881732
W.L. Gore & Associates, Inc.
Cardiovascular · 26d
Cleared Oct 01, 1984
GORE-TEX VASCULAR GRAFT, FEP-RINGED
K842144
W.L. Gore & Associates, Inc.
Cardiovascular · 124d
Cleared Dec 29, 1982
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K821826
W.L. Gore & Associates, Inc.
Cardiovascular · 190d

About Product Code DYF - Regulatory Context