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510(k) Data Aggregation

    K Number
    K172694
    Device Name
    Sterile Disposable Syringes
    Date Cleared
    2018-07-06

    (302 days)

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

    Shenyang MasTech Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sterile Disposable Syringes are intended for the injection of contrast media or saline, they shall be used with an U.S legally marketed angiographic injector.
    Device Description
    The proposed devices are available in packs, which may include different configuration of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S legally marketed angiography injector, compatibilities are shown in Table 1. The connecting tubes, which is used to connect the syringe and the catheter. The tubes are available in three configurations, which are straight tube, Type T tube and spiral tube. The different between these tubes is tube shape, which is available in straight shape for straight tube, spiral shape for spiral tube and T shape for T tube. The Type T tube is available in a various specifications to connect different model of syringe. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.
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