AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU is an FDA 510(k)-cleared medical device (K851323) manufactured by C.R. Bard, 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 11, 1985. Regulation: 8.