EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR

EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K843955) manufactured by Extracorporeal Medical Specialities, 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 November 28, 1984. Regulation: 8.