FDA Product Code DWE: Tubing, Pump, Cardiopulmonary Bypass
Leading manufacturers include LivaNova USA, Inc..
FDA 510(k) Cleared Tubing, Pump, Cardiopulmonary Bypass Devices (Product Code DWE)
About Product Code DWE - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code DWE since 1980, with 21 receiving FDA clearance (average review time: 102 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DWE have taken an average of 265 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.
DWE devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →