CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR

CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR is an FDA 510(k)-cleared medical device (K130280) 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.