NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Nanocross Elite .14 Over-the-wire Pta, Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK132777
510k NumberK132777
Device Name:NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant EV3 INC 3033 Campus Drive Plymouth,  MN  55441
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-09-05
Decision Date2013-09-26
Summary:summary

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