SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION

SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION is an FDA 510(k)-cleared medical device (K941653) 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 August 23, 1994. Regulation: 8.