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510(k) K170191

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System by Medtronic Vascular, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2017
Date Received
January 23, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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