510(k) K242429

Device

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

Applicant

Becton Dickinson Inc. (Bd)

510(k) number

K242429

Product code

SEF

Decision

Substantially Equivalent (SESE)

Decision date

2025-04-09

Date received

2024-08-15

Regulation

880.5200

Classification name

Central Venous Catheter With Manual Insertion System

Medical specialty

General Hospital

Review panel

General Hospital

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N