TRUE FLOW VALVULOPLASTY PERFUSION CATHETER

TRUE FLOW VALVULOPLASTY PERFUSION CATHETER is an FDA 510(k)-cleared medical device (K142083) 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 April 16, 2015. Regulation: 8.