MODEIFICATION TO: SMART CONTROL 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 Modeification To: Smart Control Nitinol Stent Transhepatic Biliary System.

Pre-market Notification Details

Device IDK031777
510k NumberK031777
Device Name:MODEIFICATION TO: SMART CONTROL 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 Received2003-06-10
Decision Date2003-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705032024959 K031777 000
20705032024935 K031777 000
20705032024898 K031777 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.