RX HERCULINK PLUS 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 Rx Herculink Plus Biliary Stent System.

Pre-market Notification Details

Device IDK010684
510k NumberK010684
Device Name:RX HERCULINK PLUS BILIARY STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591 -4630
ContactByron Lambert
CorrespondentByron Lambert
GUIDANT CORP. 26531 YNEZ RD. Temecula,  CA  92591 -4630
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-08
Decision Date2001-04-12

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