SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR

SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR is an FDA 510(k)-cleared medical device (K870829) 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 May 5, 1987. Regulation: 8.