VISION CARDIOPLEGIA DELIVERY SYSTEM

VISION CARDIOPLEGIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K964571) manufactured by Lifestream Int'L, 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 August 7, 1997. Regulation: 8.