COBE CMS-FS MEMBRANE OXYGENATOR

COBE CMS-FS MEMBRANE OXYGENATOR is an FDA 510(k)-cleared medical device (K926467) manufactured by Cobe Cardiovascular, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 1993. Regulation: 8.