FDA Product Code DXO: Transducer, Pressure, Catheter Tip
Leading manufacturers include Opsens, Inc., Edwards Lifesciences, LLC and Acist Medical Systems, Inc..
FDA 510(k) Cleared Transducer, Pressure, Catheter Tip Devices (Product Code DXO)
About Product Code DXO - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code DXO since 1979, with 64 receiving FDA clearance (average review time: 127 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
Recent submissions under DXO have taken an average of 249 days to reach a decision - up from 121 days historically. Manufacturers should account for longer review timelines in current project planning.
DXO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →