HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA is an FDA 510(k)-cleared medical device (K944267) 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 April 27, 1995. Regulation: 8.