Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is an FDA 510(k)-cleared medical device (K182397) manufactured by Cardiovascular Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2018. Regulation: 8.