OCS Heart Leukocyte Depleting Filter

OCS Heart Leukocyte Depleting Filter is an FDA 510(k)-cleared medical device (K231362) manufactured by TransMedics, Inc.. 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 30, 2023. Regulation: 8.