MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM

MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K971105) manufactured by Avecor 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 July 10, 1997. Regulation: 8.