FEP RINGED GORE-TEX STRETCH 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 Fep Ringed Gore-tex Stretch Vascular Graft.

Pre-market Notification Details

Device IDK922905
510k NumberK922905
Device Name:FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
ClassificationProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff,  AZ  86001
ContactJames D Lewis
CorrespondentJames D Lewis
W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff,  AZ  86001
Product CodeDSY  
CFR Regulation Number870.3450 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-16
Decision Date1992-11-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H373SRT08012030L3L K922905 000
H373SRD06005045L3B K922905 000

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