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510(k) Data Aggregation

    K Number
    K182289
    Device Name
    Sterile High-pressure Angiographic Syringes for Single-use
    Manufacturer
    Shenzhen Baoan Medical Supplies Co., Ltd
    Date Cleared
    2018-10-10

    (48 days)

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

    Shenzhen Baoan Medical Supplies Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an US legally marketed angiographic injectors.
    Device Description
    The proposed devices include 2 models of plastic, disposable syringes and 5 connection tubes of different specifications. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes are used to connect the syringe and the catheter. The tubes are also available in three configurations, which are straight tube (used with single shot syringe), type Y and type T tube (used with dual shot syringe), they can withstand maximum pressure of 400 psi. The proposed devices are used with the J shape tube / spike cleared in K151960.
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    K Number
    K151960
    Device Name
    Sterile High-pressure Angiographic Syringes for Single-use
    Manufacturer
    SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
    Date Cleared
    2016-01-07

    (175 days)

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

    SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile High-pressure Angiographic Syringes for Single-use are intended for the injection of contrast media or saline; they shall be used with an 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.
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