OMNILINK .035 BILIARY STENT SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

GUIDANT CORP.

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

Pre-market Notification Details

Device IDK011506
510k NumberK011506
Device Name:OMNILINK .035 BILIARY STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactCurtis Truesdale
CorrespondentCurtis Truesdale
GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-16
Decision Date2001-06-15

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