AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Axillobifemoral Gore-tex Vascular Graft.

Pre-market Notification Details

Device IDK901641
510k NumberK901641
Device Name:AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff,  AZ  86002
ContactVicki Lewis
CorrespondentVicki Lewis
W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff,  AZ  86002
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-09
Decision Date1990-09-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00733132611782 K901641 000
00733132611768 K901641 000

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