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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 K170191
Device Name SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
Applicant
MEDTRONIC VASCULAR, INC.
3033 CAMPUS DRIVE
PLYMOUTH,  MN  55441
Applicant Contact AARON HAGE
Correspondent
MEDTRONIC VASCULAR, INC.
3033 CAMPUS DRIVE
PLYMOUTH,  MN  55441
Correspondent Contact AARON HAGE
Regulation Number870.4875
Classification Product Code
MCW  
Date Received01/23/2017
Decision Date 06/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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