SARNS MEMBRANE OXGENATOR PART NUMBER 9443

SARNS MEMBRANE OXGENATOR PART NUMBER 9443 is an FDA 510(k)-cleared medical device (K903436) manufactured by 3M Health Care, Sarns. 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 18, 1990. Regulation: 8.