MODIFIED SARNS MEMBRANE OXYGENATOR

MODIFIED SARNS MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K863902) 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 December 10, 1986. Regulation: 8.