FILTER, ARTERIAL BLOOD W/TUBING BYPASS

FILTER, ARTERIAL BLOOD W/TUBING BYPASS is an FDA 510(k)-cleared medical device (K781707) manufactured by Surgikos, 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 25, 1978. Regulation: 8.