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

    Sterile High-pressure Angiographic Syringes for Single-use

    K Number: K182289 · Decision Oct 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    Sterile High-pressure Angiographic Syringes for Single-use
    K Number
    K182289
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Baoan Medical Supplies Co., Ltd.
    Date Received
    August 23, 2018
    Decision Date
    October 10, 2018
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    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 Shenzhen Baoan Medical Supplies Co., Ltd.

    K Number Device Name
    K151960 Sterile High-pressure Angiographic Syringes for Single-use