FDA 510(k), K141801, HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
FDA 510(k), K141801, HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
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
Total pages: 1214
Fully redacted pages: 1083
Content pages: 131
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