RAPIDCROSS PTA RAPID EXCHANGE, BALLOON 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 Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter.

Pre-market Notification Details

Device IDK123544
510k NumberK123544
Device Name:RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant EV3 INC 3033 CAMPUS DRIVE Plymouth,  MN  55441 -2651
ContactLaura J Lind
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 Received2012-11-19
Decision Date2013-02-12
Summary:summary

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