PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS is an FDA 510(k)-cleared medical device (K931444) manufactured by Sorin Biomedica, Fiat, USA, 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 May 26, 1994. Regulation: 8.