THE SAMUELS RETROGRAD VALVULOTOME

THE SAMUELS RETROGRAD VALVULOTOME is an FDA 510(k)-cleared medical device (K932009) manufactured by Vascutech, 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 20, 1993. Regulation: 8.