AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

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 Cascular Graft,bifurcated.

Pre-market Notification Details

Device IDK941981
510k NumberK941981
Device Name:AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff,  AZ  86001 -0300
ContactVicki Lewis
CorrespondentVicki Lewis
W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff,  AZ  86001 -0300
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSe Subject To Traking & Pms (PT)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-14
Decision Date1994-07-20

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