OXYGENATOR, BLOOD, INFANT/PEDIATRIC

OXYGENATOR, BLOOD, INFANT/PEDIATRIC is an FDA 510(k)-cleared medical device (K781223) manufactured by Shiley, 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 July 26, 1978. Regulation: 8.