ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER is an FDA 510(k)-cleared medical device (K991137) manufactured by Minntech Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2000. Regulation: 8.