MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge is an FDA 510(k)-cleared medical device (K162958) manufactured by Medtronic, 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 January 31, 2017. Regulation: 8.