PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K050447) manufactured by Dideco S.R.L.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 7, 2005. Regulation: 8.