HALO ABLATION CATHETER

HALO ABLATION CATHETER is an FDA 510(k)-cleared medical device (K083737) 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 February 9, 2009. Regulation: 8.