SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380

SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 is an FDA 510(k)-cleared medical device (K895632) manufactured by 3M Company. 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 11, 1989. Regulation: 8.