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510(k) Data Aggregation
K Number
K242429Device Name
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System
Manufacturer
Becton Dickinson Inc. (BD)
Date Cleared
2025-04-09
(237 days)
Product Code
SEF
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton Dickinson Inc. (BD)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
Device Description
Vena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories.
The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism.
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