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510(k) Data Aggregation

    K Number
    K240355
    Device Name
    FROG (Filter Removal of Glass)
    Manufacturer
    CarrTech Corp
    Date Cleared
    2025-04-18

    (438 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    CarrTech Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    • The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering. • The FROG removable filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover. • The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.
    Device Description
    The FROG device is a prescription device intended for use by healthcare professionals in a healthcare or outpatient setting. The FROG device incorporates a removable filter, which surrounds the hypodermic needle and allows the filtered aspiration of glass-contaminated drug into the syringe. After aspiration, the filter is removed from the device, permitting injection with the hypodermic needle which is already attached to the syringe. Each package will include an assembled FROG device. The device is intended for single use and provided sterile.
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