CSS-CARDIOPLEGIA SAFETY SYSTEM

CSS-CARDIOPLEGIA SAFETY SYSTEM is an FDA 510(k)-cleared medical device (K973237) manufactured by Medtronic Bio-Medicus, 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 26, 1998. Regulation: 8.