SEF · Class II · 21 CFR 880.5200

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
1–1 of 1
Cleared Apr 09, 2025
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
K242429
Becton Dickinson Inc. (Bd)
General Hospital · 237d

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.

SEF devices are reviewed by the General Hospital panel. Browse all General Hospital devices →