SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K904171) manufactured by Scimed. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1990. Regulation: 8.