MAXIMA PLUS HOLLOW FIBER OXYGENATOR

MAXIMA PLUS HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K925626) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 4, 1993. Regulation: 8.