Barrx RFA Self Sizing Balloon Catheter

Barrx RFA Self Sizing Balloon Catheter is an FDA 510(k)-cleared medical device (K142364) manufactured by Covidien, LLC. 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 September 30, 2014. Regulation: 8.