HALO360' COAGULATION CATHETER

HALO360' COAGULATION CATHETER is an FDA 510(k)-cleared medical device (K071543) manufactured by Barrx Medical, Incorporated. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 28, 2007. Regulation: 8.