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 Qura S.R.L.
FDA 510(k) Cleared Oxygenator, Cardiopulmonary Bypass Devices (Product Code DTZ)
About Product Code DTZ - Regulatory Context
510(k) Submission Activity
254 total 510(k) submissions under product code DTZ since 1976, with 254 receiving FDA clearance (average review time: 134 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under DTZ have taken an average of 304 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.
DTZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →