TRUE BA V BALLOON VALVULOPLASTY CATHETER

TRUE BA V BALLOON VALVULOPLASTY CATHETER is an FDA 510(k)-cleared medical device (K141985) manufactured by C.R. Bard, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 17, 2014. Regulation: 8.