MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Cordis Palmaz Genesis Transhepatic Biliary Stent On Slalom .018 Delivery System.

Pre-market Notification Details

Device IDK021345
510k NumberK021345
Device Name:MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 7 POWDER HORN DR. Warren,  NJ  07059
ContactKaren Wilk
CorrespondentKaren Wilk
CORDIS CORP. 7 POWDER HORN DR. Warren,  NJ  07059
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-29
Decision Date2002-06-28
Summary:summary

NIH GUDID Devices

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