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

    Sunsphere

    K Number: K232934 · Decision May 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    253

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    Basic Information

    Device Name
    Sunsphere
    K Number
    K232934
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Yangshun Medical Technology Co.,Ltd
    Date Received
    September 20, 2023
    Decision Date
    May 30, 2024
    Product Code
    KRD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization

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