PTFE RINGED GORE-TEX VASCULAR GRAFT

Prosthesis, Vascular Graft, Of Less Then 6mm 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 Ptfe Ringed Gore-tex Vascular Graft.

Pre-market Notification Details

Device IDK991683
510k NumberK991683
Device Name:PTFE RINGED GORE-TEX VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff,  AZ  86001 -0300
ContactTimothy J Rynn
CorrespondentTimothy J Rynn
W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 Flagstaff,  AZ  86001 -0300
Product CodeDYF  
CFR Regulation Number870.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-17
Decision Date1999-09-08
Summary:summary

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