MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF

MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF is an FDA 510(k)-cleared medical device (K914742) manufactured by Medtronic Vascular. 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 3, 1991. Regulation: 8.