CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE

CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE is an FDA 510(k)-cleared medical device (K961734) 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 July 6, 1997. Regulation: 8.