2.4mm X 127 cm Phoenix Atherectomy Deflecting System

2.4mm X 127 cm Phoenix Atherectomy Deflecting System is an FDA 510(k)-cleared medical device (K151145) 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 May 25, 2015. Regulation: 8.