SEF

Central Venous Catheter With Manual Insertion System

Product code

SEF

Device name

Central Venous Catheter With Manual Insertion System

Device class

Class 2

21 CFR

21 CFR 880.5200

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-09.

1 summaries are archived here for direct download.