CORDIS NITINOL STENT AND 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 Nitinol Stent And Delivery System.

Pre-market Notification Details

Device IDK980823
510k NumberK980823
Device Name:CORDIS NITINOL STENT AND DELIVERY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant CORDIS CORP. 40 TECHNOLOGY DR. P.O. BOX 4917 Warren,  NJ  07059
ContactJoan Martin
CorrespondentJoan Martin
CORDIS CORP. 40 TECHNOLOGY DR. P.O. BOX 4917 Warren,  NJ  07059
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-03
Decision Date1998-12-18
Summary:summary

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