TERUMO HOLLOW FIBER OXYGENATOR

TERUMO HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K812660) manufactured by Terumo Medical Corp.. 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 13, 1981. Regulation: 8.