QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS

QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS is an FDA 510(k)-cleared medical device (K132829) manufactured by Maquet Cardiopulmonary, AG. 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 7, 2013. Regulation: 8.