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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 K141801
Device Name HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Applicant
COVIDIEN, LLC
3033 CAMPUS DRIVE
PLYMOUTH,  MN  55442
Applicant Contact JULIE UNDERDAHL
Correspondent
COVIDIEN, LLC
3033 CAMPUS DRIVE
PLYMOUTH,  MN  55442
Correspondent Contact JULIE UNDERDAHL
Regulation Number870.4875
Classification Product Code
MCW  
Date Received07/03/2014
Decision Date 10/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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