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510(k) Data Aggregation

    K Number
    K021471
    Date Cleared
    2003-09-08

    (488 days)

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

    The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.

    Device Description

    The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.

    AI/ML Overview

    I'm sorry, I cannot fulfill this request. The provided text is a U.S. Food and Drug Administration (FDA) clearance letter for a medical device (Marquette Huber Trap Safety Infusion Set). This type of document typically does not contain the detailed study information required to answer the requested questions about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment.

    FDA clearance letters primarily state that a device has been found substantially equivalent to a legally marketed predicate device and outline regulatory compliance requirements. They do not usually include the clinical study results or technical details that would allow me to populate the table and answer the specific questions about the device's performance characteristics or the studies used to prove them.

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