BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    High Pressure Tubing

    K Number: K244038 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    2
    Review Days
    249

    Basic Information

    Device Name
    High Pressure Tubing
    K Number
    K244038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Int Medical Instruments Co., Ltd.
    Date Received
    December 30, 2024
    Decision Date
    September 5, 2025
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Shandong Int Medical Instruments Co., Ltd.

    K Number Device Name
    K242143 Angiography Injector