CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR

CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR is an FDA 510(k)-cleared medical device (K130493) manufactured by Terumo Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2013. Regulation: 8.