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

    Sterile High-pressure Angiographic Syringes for Single-use

    K Number: K211564 · Decision Oct 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    3
    Review Days
    152

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    Basic Information

    Device Name
    Sterile High-pressure Angiographic Syringes for Single-use
    K Number
    K211564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Boon Medical Supply Co., Ltd.
    Date Received
    May 20, 2021
    Decision Date
    October 19, 2021
    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 Shenzhen Boon Medical Supply Co., Ltd.

    K Number Device Name
    K241109 Single-use Sterile High-pressure Angiographic Syringes and Accessories
    K192657 Sterile High-pressure Angiographic Syringes for Single-use