FDA Product Code SEF: Central Venous Catheter With Manual Insertion System
A Central Venous Catheter With Manual Insertion System Is Intended To Provide Short-term Access (<30 Days) To The Central Venous System. The Manual Insertion System Is Attached To The Catheter And Facilitates Placement In The Targeted Vessel.
Leading manufacturers include Becton Dickinson Inc. (Bd).
1
Total
1
Cleared
237d
Avg days
2025
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Central Venous Catheter With Manual Insertion System Devices (Product Code SEF)
1 devices
About Product Code SEF - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SEF since 2025, with 1 receiving FDA clearance (average review time: 237 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.