MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR

MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K897068) 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 August 27, 1991. Regulation: 8.