FDA Product Code DTR: Heat-exchanger, Cardiopulmonary Bypass
Leading manufacturers include Medtronic, Spectrum Medical , Ltd. and Sorin Group Italia S.R.L..
FDA 510(k) Cleared Heat-exchanger, Cardiopulmonary Bypass Devices (Product Code DTR)
About Product Code DTR - Regulatory Context
510(k) Submission Activity
91 total 510(k) submissions under product code DTR since 1977, with 91 receiving FDA clearance (average review time: 112 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DTR have taken an average of 268 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
DTR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →