CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 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 Cordis Palmaz Genesis Transhepatic Biliary Stent On Opta Pro .035 Delivery System.

Pre-market Notification Details

Device IDK012590
510k NumberK012590
Device Name:CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 7 POWDER HORN DR. Warren,  NJ  07059
ContactCharles (chuck) J Ryan
CorrespondentCharles (chuck) J Ryan
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 Received2001-08-10
Decision Date2001-09-07
Summary:summary

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