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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 K103322
Device Name EVERCROSS 0.035 OTW PTA DILATION CATHETER
Applicant
EV3 INC
3033 Campus Drive
Plymouth,  MN  55441
Applicant Contact DAVID WORRELL, MS, RAC
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number870.1250
Classification Product Code
LIT  
Date Received11/12/2010
Decision Date 12/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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