PERFADEX SOLUTION FOR LUNG PRESERVATION

PERFADEX SOLUTION FOR LUNG PRESERVATION is an FDA 510(k)-cleared medical device (K022730) manufactured by Vitrolife AB. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2003. Regulation: 8.