MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR

MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K004001) manufactured by Dideco. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 2001. Regulation: 8.