CROSSER CTO Recanalization Catheter

CROSSER CTO Recanalization Catheter is an FDA 510(k)-cleared medical device (K161208) manufactured by Bard Peripheral Vacular, 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 23, 2016. Regulation: 8.