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510(k) Data Aggregation

    K Number
    K122321
    Device Name
    BASIXCONPAK ANALOG INFLATION SYRINGE
    Manufacturer
    MERIT MEDICAL IRELAND, LTD.
    Date Cleared
    2012-12-19

    (140 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERIT MEDICAL IRELAND, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
    Device Description
    The Merit analog inflation syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube. It is provided with a 510(k)-cleared three way medium pressure stopcock.
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