SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM

SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K853516) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 1985. Regulation: 8.