NEW COBE CARDIOPLEGIA SYSTEM

NEW COBE CARDIOPLEGIA SYSTEM is an FDA 510(k)-cleared medical device (K920312) 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 30, 1992. Regulation: 8.