COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS is an FDA 510(k)-cleared medical device (K964043) 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 September 28, 1997. Regulation: 8.