APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR

APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K092895) manufactured by Sorin Group Italia 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 October 18, 2009. Regulation: 8.