VIABIL BILIARY ENDOPROSTHESIS

Stents, Drains And Dilators For The Biliary Ducts

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 Viabil Biliary Endoprosthesis.

Pre-market Notification Details

Device IDK041423
510k NumberK041423
Device Name:VIABIL BILIARY ENDOPROSTHESIS
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
ContactMichael Ivey
CorrespondentMichael Ivey
W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff,  AZ  86001
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-28
Decision Date2004-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00733132615414 K041423 000

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