CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR

CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR is an FDA 510(k)-cleared medical device (K961000) 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 October 1, 1996. Regulation: 8.