DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K133399) manufactured by Cardiovascular Systems Incorporated. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 2013. Regulation: 8.