Phoenix 2.4mm Atherectomy Plus System

Phoenix 2.4mm Atherectomy Plus System is an FDA 510(k)-cleared medical device (K181877) manufactured by Volcano Atheromed, 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 16, 2018. Regulation: 8.