FDA Product Code DTN: Reservoir, Blood, Cardiopulmonary Bypass
Leading manufacturers include Sorin Group Italia S.R.L., Medtronic Cardiac Surgery and Spectrum Medical S.R.L..
FDA 510(k) Cleared Reservoir, Blood, Cardiopulmonary Bypass Devices (Product Code DTN)
About Product Code DTN - Regulatory Context
510(k) Submission Activity
169 total 510(k) submissions under product code DTN since 1976, with 169 receiving FDA clearance (average review time: 109 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for DTN submissions have been consistent, averaging 100 days recently vs 109 days historically.
DTN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →