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510(k) Data Aggregation

    K Number
    K012879
    Device Name
    EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-01-17

    (142 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.

    Device Description

    Huber Infusion Set with Needleless Injection Site

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a letter from the FDA regarding a 510(k) premarket notification for an "Exel Huber Infusion Set with Needleless Injection Site." It confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed, subject to general controls and other regulations.

    The document does not detail any performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. It primarily focuses on the regulatory approval process.

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