PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

Stents, Drains And Dilators For The Biliary Ducts

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Protege Gps Self-expanding Nitinol Stent And Delivery System.

Pre-market Notification Details

Device IDK033314
510k NumberK033314
Device Name:PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant EV3 INC 4600 NATHAN LN. NORTH Plymouth,  MN  55442 -2920
ContactGlen D Smythe
CorrespondentGlen D Smythe
EV3 INC 4600 NATHAN LN. NORTH Plymouth,  MN  55442 -2920
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-15
Decision Date2003-11-21
Summary:summary

NIH GUDID Devices

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