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510(k) Data Aggregation

    K Number
    K201395
    Device Name
    Sterile High-pressure Angiographic Syringes for single-use
    Manufacturer
    Youwo (Guangzhou) Medical Device Co., Ltd.
    Date Cleared
    2020-10-28

    (154 days)

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

    Youwo (Guangzhou) Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.
    Device Description
    The proposed devices are available in packs, which may include different configurations 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 connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube. 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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