AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511

AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 is an FDA 510(k)-cleared medical device (K000430) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2000. Regulation: 8.