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510(k) Data Aggregation

    K Number
    K192493
    Device Name
    BD Cathena (TM) Safety IV Catheter
    Manufacturer
    Becton, Dickinson Infusion Therapy Systems, Inc.
    Date Cleared
    2020-01-24

    (135 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Becton, Dickinson Infusion Therapy Systems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Cathena™ Safety IV Catheters are intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
    Device Description
    BD Cathena™ Safety IV Catheters are over-the-needle, intravascular (IV) catheters. These devices include a radiopaque BD Vialon™ catheter, needle, grip, passive safety needle shield, and flash chamber with removable vent plug. The needle and catheter are protected by a needle cover. These devices have BD Instaflash™ Needle Technology, allowing for immediate visualization of blood along the catheter. The flash chamber provides confirmation that the device has entered the vessel. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices are available with or without multi-access BD Multiguard technology, which is designed to stop the flow of blood from the catheter hub until a Luer connection is made. Once a connection is made, fluids or blood can flow through the catheter hub in either direction. These devices are available with or without wings. The catheter hub and wings are color coded to indicate the catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green, 16 GA (1.7 mm) = Grey). These devices are not made with natural rubber latex.
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