PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR

PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K901249) 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 June 10, 1990. Regulation: 8.