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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 K161361
Device Name HawkOne Directional Atherectomy System
Applicant
Medtronic Vascular, Inc.
(formerly d.b.a ev3 Inc., Covidien llc)
3033 Campus Drive
Plymouth,  MN  55441
Applicant Contact Rupali Gupta
Correspondent
Medtronic Vascular, Inc.
(formerly d.b.a ev3 Inc., Covidien llc)
3033 Campus Drive
Plymouth,  MN  55441
Correspondent Contact Rupali Gupta
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/16/2016
Decision Date 10/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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