HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM

HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K141801) manufactured by Covidien, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 15, 2014. Regulation: 8.