GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58

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 Guidant Megalink Biliary Stent, Model Fg1002949-58.

Pre-market Notification Details

Device IDK991032
510k NumberK991032
Device Name:GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactKobby Dankwah
CorrespondentKobby Dankwah
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 Received1999-03-29
Decision Date1999-04-30
Summary:summary

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