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510(k) Data Aggregation

    K Number
    K113600
    Device Name
    IM BAND
    Manufacturer
    SYNEXMED (SHENZHEN) COMPANY LIMITED
    Date Cleared
    2012-02-08

    (65 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNEXMED (SHENZHEN) COMPANY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IM Band ™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.
    Device Description
    The IM Band TM Adjustable Arterial Compression Band is intended to be used to oppress the vascular puncture in order to stop the bleeding by the inflation of a balloon. Transparent balloon material allows clear monitoring of the hemostasis time. Oppressing inside the balloon can be adapt to the skin surface for better contact. Bleeding can be stopped by simply adjusting the band or turncap according to doctor's instruction. Soft and adjustable wrist band enhances patient comfort.
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