FDA 510(k) Applications for Medical Device Product Code "DYF"
(Prosthesis, Vascular Graft, Of Less Then 6mm Diameter)

FDA 510(k) Number Applicant Device Name Decision Date
K992441 ATRIUM MEDICAL CORP. ADVANTA GRAFT 08/20/1999
K992958 ATRIUM MEDICAL CORP. ADVANTA GRAFT (<6MM) 10/01/1999
K000504 ATRIUM MEDICAL CORP. ADVANTA SUPER SOFT GRAFT 03/01/2000
K933391 ATRIUM MEDICAL CORP. ATRIUM'S HYBRID PTFE 12/15/1994
K944844 BAXTER HEALTHCARE CORP. BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT 03/31/1995
K983769 IMPRA, INC. DISTAFLO BYPASS GRAFT 12/15/1998
K004012 IMPRA, INC. IMPRA CARBOFLO EPTFE VASCULAR GRAFTS 05/14/2001
K964877 IMPRA, INC. IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT 03/20/1997
K924360 IMPRA, INC. IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS) 11/25/1992
K791810 IMPRA, INC. VASCULAR GRAFT PROST. OF EXPANDED PTFE 10/09/1979
K981076 IMPRA, INC. VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT 05/07/1998
K960766 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT 03/19/1997
K984183 POSSIS MEDICAL, INC. PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 02/01/1999
K955533 W.L. GORE & ASSOCIATES,INC DIASTAT VASCULAR ACCESS GRAFT 05/15/1996
K953287 W.L. GORE & ASSOCIATES,INC DIASTAT VASCULAR ACCESS GRAFT 10/06/1995
K940824 W.L. GORE & ASSOCIATES,INC DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III 05/04/1994
K934726 W.L. GORE & ASSOCIATES,INC FEP RINGED GORE-TEX VASCULAR GRAFT 12/08/1993
K821826 W.L. GORE & ASSOCIATES,INC FEP-RINGED "GORE-TEX@ VASCULAR GRAFT" 12/29/1982
K881732 W.L. GORE & ASSOCIATES,INC GORE-TEX VASCULAR GRAFT 05/18/1988
K842144 W.L. GORE & ASSOCIATES,INC GORE-TEX VASCULAR GRAFT, FEP-RINGED 10/01/1984
K991683 W.L. GORE & ASSOCIATES,INC PTFE RINGED GORE-TEX VASCULAR GRAFT 09/08/1999


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