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

    TK Intravascular Administration Set

    K Number: K191640 · Decision Aug 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    12
    Review Days
    434

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    Basic Information

    Device Name
    TK Intravascular Administration Set
    K Number
    K191640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Tiankang Medical Technology Co., Ltd.
    Date Received
    June 19, 2019
    Decision Date
    August 26, 2020
    Product Code
    FPA
    Advisory Committee
    General Hospital
    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
    FPA Set, Administration, Intravascular

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