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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 K123544
Device Name RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
Applicant
Ev3, Inc.
3033 Campus Dr.
Plymouth,  MN  55441 -2651
Applicant Contact LAURA J LIND
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received11/19/2012
Decision Date 02/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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