True Dilatation Balloon Valvuloplasty Catheter

True Dilatation Balloon Valvuloplasty Catheter is an FDA 510(k)-cleared medical device (K150667) 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 June 16, 2015. Regulation: 8.