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 Medtronic Perfusion Systems.
List of Oxygenator, Cardiopulmonary Bypass devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Oxygenator, Cardiopulmonary Bypass devices (product code DTZ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →