MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

GUIDANT CORPORATION

The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Modification To Omnilink .035 Biliary Stent System.

Pre-market Notification Details

Device IDK032530
510k NumberK032530
Device Name:MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant GUIDANT CORPORATION 1525 O'BRIEN DR. Menlo Park,  CA  94025
ContactMichelle Grossman
CorrespondentMichelle Grossman
GUIDANT CORPORATION 1525 O'BRIEN DR. Menlo Park,  CA  94025
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-15
Decision Date2003-10-23
Summary:summary

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