MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS

MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS is an FDA 510(k)-cleared medical device (K920889) 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 September 14, 1992. Regulation: 8.