WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR

WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K894970) 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 October 31, 1989. Regulation: 8.