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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K111723
Device Name TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Applicant
Ev3, Inc.
3033 Campus Dr.
Plymouth,  MN  55441
Applicant Contact BRENDA JOHNSON
Correspondent
Ev3, Inc.
3033 Campus Dr.
Plymouth,  MN  55441
Correspondent Contact BRENDA JOHNSON
Regulation Number870.4875
Classification Product Code
MCW  
Date Received06/20/2011
Decision Date 10/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00733135
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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