AOR-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 Aor-tex Vascular Graft.

Pre-market Notification Details

Device IDK933987
510k NumberK933987
Device Name:AOR-TEX VASCULAR GRAFT
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 Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-17
Decision Date1994-05-17

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