True Flow Valvuloplasty Perfusion Catheter

True Flow Valvuloplasty Perfusion Catheter is an FDA 510(k)-cleared medical device (K172932) 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 December 12, 2017. Regulation: 8.