# K242429: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Inc. (Bd)
- Decided: Apr 9, 2025 after 237 days
- Product code: SEF (Central Venous Catheter With Manual Insertion System)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
4 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190855: BD Acute Central Line, Bard Access Systems, Inc. (Bard Has Joined Bd) (2019) Summary page 7.

## Indications for use
CentroVena Central Venous Catheter (CVC) Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting CentroVena One Insertion System The CentroVena One Insertion System is indicated to facilitate the insertion of the included central venous catheters. Acute central venous catheters are indicated to provide short term access (< 30 days) to the central venous system. They are designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media. 7F Triple Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Distal Lumen, 9 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Triple Lumen Catheter Size, 30 cm Catheter Length, Medial/Proximal Lumen, 7 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Distal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting 7F Dual Lumen Catheter Size, 16 cm and 20 cm Catheter Length, Medial/Proximal Lumen, 10 mL/s Power Injection Flow Rate, 325 psi Maximum Power Injector Pressure Setting

Source page: https://510kreport.com/device/K242429
Methodology: https://510kreport.com/methodology