FDA Product Code DTZ: Oxygenator, Cardiopulmonary Bypass

The heart-lung machine depends on a reliable oxygenator to sustain patients during open-heart surgery. FDA product code DTZ covers cardiopulmonary bypass oxygenators.

These devices perform gas exchange outside the body — adding oxygen and removing carbon dioxide from venous blood during cardiopulmonary bypass, temporarily replacing the function of the lungs. Modern hollow-fiber membrane oxygenators minimize blood trauma and reduce post-operative complications.

DTZ devices are Class II medical devices, regulated under 21 CFR 870.4350 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Sorin Group Italia S.R.L., Medtronic, Inc. and American Bentley.