
Barrx Medical, Inc.
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HALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200 is an FDA 510(k)-cleared medical device (K101111) 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 June 17, 2010. Regulation: 8.