TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B

TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B is an FDA 510(k)-cleared medical device (K011864) 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 July 8, 2001. Regulation: 8.