FDA Product Code DXF: Catheter, Septostomy
Leading manufacturers include Circa Scientific, Inc., Atraverse Medical and NuMED, Inc..
FDA 510(k) Cleared Catheter, Septostomy Devices (Product Code DXF)
About Product Code DXF - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code DXF since 1980, with 20 receiving FDA clearance (average review time: 112 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DXF have taken an average of 70 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
DXF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →