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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 K212027
Device Name TurboHawk Plus Directional Atherectomy System
Applicant
Medtronic, Inc
4600 Nathan Lane North
Plymouth,  MN  55442
Applicant Contact Jenny Andersen
Correspondent
Medtronic, Inc
4600 Nathan Lane North
Plymouth,  MN  55442
Correspondent Contact Jenny Andersen
Regulation Number870.4875
Classification Product Code
MCW  
Date Received06/29/2021
Decision Date 08/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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