PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT 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 Everflex Self-expanding Biliary Stent System.

Pre-market Notification Details

Device IDK060057
510k NumberK060057
Device Name:PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant EV3 INC. 4600 NATHAN LN. NORTH Plymouth,  MN  55442 -2920
ContactMelissa Sommerfeld
CorrespondentMelissa Sommerfeld
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 Received2006-01-09
Decision Date2006-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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