MODIFICATION TO NITREX NITINOL GUIDEWIRE

Wire, Guide, Catheter

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Modification To Nitrex Nitinol Guidewire.

Pre-market Notification Details

Device IDK040345
510k NumberK040345
Device Name:MODIFICATION TO NITREX NITINOL GUIDEWIRE
ClassificationWire, Guide, Catheter
Applicant EV3 INC 4600 NATHAN LN. NORTH Plymouth,  MN  55442 -2920
ContactCarolyn Anderson
CorrespondentCarolyn Anderson
EV3 INC 4600 NATHAN LN. NORTH Plymouth,  MN  55442 -2920
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-02-12
Decision Date2004-03-02
Summary:summary

NIH GUDID Devices

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