MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

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 Modification To Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,.

Pre-market Notification Details

Device IDK993588
510k NumberK993588
Device Name:MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactSanta Sundell
CorrespondentSanta Sundell
GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-22
Decision Date1999-11-17
Summary:summary

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