BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP

Stents, Drains And Dilators For The Biliary Ducts

BARD PERIPHERAL VASCULAR, INC.

The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard Conformexx Biliary Stent With The Performaxx Grip.

Pre-market Notification Details

Device IDK052114
510k NumberK052114
Device Name:BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe,  AZ  85280 -1740
ContactDennis Salzmann
CorrespondentDennis Salzmann
BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe,  AZ  85280 -1740
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-04
Decision Date2005-08-25
Summary:summary

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