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510(k) Data Aggregation

    K Number
    K962802
    Date Cleared
    1996-08-28

    (41 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These I.V. Fluid Delivery Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Fluid Delivery Sets provide for the entry into an intravascular administration system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

    Device Description

    The B.E.C. Safe Mate I.V. Fluid Delivery Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector or an attached schrouded plastic cannula at one end intended to connect to an I.V. catheter, needle or a split septum injection site extension set affixed to an I.V. catheter. Fluid delivery set lengths may vary from 60" up to 120" or longer. Fluid Delivery Sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes an "I.V. Fluid Delivery Set" and its components, and lists various contact details and a date, but it does not detail any acceptance criteria, study data, or performance metrics for the device. Without this information, I cannot complete the table or answer the specific questions about the study and ground truth.

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