COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K963518) manufactured by Cobe Cardiovascular, Inc.. 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 7, 1997. Regulation: 8.