EVERCROSS 0.035 OTW PTA DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Evercross 0.035 Otw Pta Dilatation Catheter.

Pre-market Notification Details

Device IDK110319
510k NumberK110319
Device Name:EVERCROSS 0.035 OTW PTA DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant EV3 INC 3033 Campus Drive Plymouth,  MN  55441
ContactPaula Cordero
CorrespondentPaula Cordero
EV3 INC 3033 Campus Drive Plymouth,  MN  55441
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-03
Decision Date2011-04-14
Summary:summary

NIH GUDID Devices

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