PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY 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 Precise Rx Nitinol Stent Transhepatic Biliary System.

Pre-market Notification Details

Device IDK032137
510k NumberK032137
Device Name:PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
ContactSam Mirza
CorrespondentSam Mirza
CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes,  FL  33014
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-11
Decision Date2003-09-17
Summary:summary

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