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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, angioplasty, peripheral, transluminal
510(k) Number K130911
Device Name RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
Applicant
EV3 INC.
3033 Campus Drive
Plymouth,  MN  55441
Applicant Contact LAURA J LIND
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/02/2013
Decision Date 05/24/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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