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Cobe Cardiovascular, Inc.
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MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM is an FDA 510(k)-cleared medical device (K012898) 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 16, 2001. Regulation: 8.