MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. is an FDA 510(k)-cleared medical device (K891230) manufactured by Medtronic Blood Systems, 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 18, 1989. Regulation: 8.