HALO90 ULTRA ABLATION CATHETER

HALO90 ULTRA ABLATION CATHETER is an FDA 510(k)-cleared medical device (K120431) manufactured by Barrx Medical, Inc.. 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 May 2, 2012. Regulation: 8.