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510(k) Data Aggregation

    K Number
    K232577
    Device Name
    Radial Compression Device
    Manufacturer
    Ningbo DIZEGENS Medical Science Co., Ltd.
    Date Cleared
    2024-01-18

    (146 days)

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

    Ningbo DIZEGENS Medical Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.
    Device Description
    The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.
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    K Number
    K232388
    Device Name
    High Pressure Tubing
    Manufacturer
    Ningbo DIZEGENS Medical Science Co., Ltd.
    Date Cleared
    2023-11-21

    (104 days)

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

    Ningbo DIZEGENS Medical Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.
    Device Description
    High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.
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