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FDA 510(k), K161361, HawkOne Directional Atherectomy System
FDA 510(k), K161361, HawkOne Directional Atherectomy System
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510(K) Number: K161361
Device Name: HawkOne Directional Atherectomy System
Manufacturer: Medtronic Vascular, Inc.
Device Classification Name: Catheter, Peripheral, Atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 05/16/2016
Decision Date: 10/14/2016
Regulation Medical Specialty: Cardiovascular
Device Name: HawkOne Directional Atherectomy System
Manufacturer: Medtronic Vascular, Inc.
Device Classification Name: Catheter, Peripheral, Atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 05/16/2016
Decision Date: 10/14/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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