COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR

COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR is an FDA 510(k)-cleared medical device (K974812) 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 May 31, 1998. Regulation: 8.