FDA 510(k), K141801, HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
FDA 510(k), K141801, HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
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510(K) Number: K141801
Device Name: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Manufacturer: COVIDIEN, LLC
Device Classification Name: Catheter, Peripheral, Atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 07/03/2014
Decision Date: 10/16/2014
Regulation Medical Specialty: Cardiovascular
Device Name: HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Manufacturer: COVIDIEN, LLC
Device Classification Name: Catheter, Peripheral, Atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 07/03/2014
Decision Date: 10/16/2014
Regulation Medical Specialty: Cardiovascular
- 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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