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 IDK032580
510k NumberK032580
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
ContactGlen D Smythe
CorrespondentGlen D Smythe
EV3 INC 4600 NATHAN LN. NORTH Plymouth,  MN  55442
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-21
Decision Date2003-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684071489 K032580 000
00821684071403 K032580 000
00821684071410 K032580 000
00821684071427 K032580 000
00821684071434 K032580 000
00821684071441 K032580 000
00821684071458 K032580 000
00821684071465 K032580 000
00821684071472 K032580 000
00821684071397 K032580 000

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