COAXIAL DUAL FLOW CATHETER

COAXIAL DUAL FLOW CATHETER is an FDA 510(k)-cleared medical device (K791411) manufactured by Terumo America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1979. Regulation: 8.