DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD

DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD is an FDA 510(k)-cleared medical device (K910107) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 1991. Regulation: 8.