SEF — Central Venous Catheter With Manual Insertion System Class II

FDA Device Classification

Classification Details

Product Code
SEF
Device Class
Class II
Regulation Number
880.5200
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242429becton dickinson inc. (bd)CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SysteApril 9, 2025