BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Sunmed Control Syringes

    K Number: K160190 · Decision Nov 10, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    6
    Review Days
    288

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    Basic Information

    Device Name
    Sunmed Control Syringes
    K Number
    K160190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunny Medical Device (Shenzhen) Co., Ltd.
    Date Received
    January 27, 2016
    Decision Date
    November 10, 2016
    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 Sunny Medical Device (Shenzhen) Co., Ltd.

    K Number Device Name
    K191827 Sunmed Disposable Angio-Closure Pads
    K153685 Sunmed Haemostatic Valves
    K140356 SUMMED HIGH PRESSURE LINE
    K133795 SUMMED INFLATION DEVICE KIT
    K120119 SUNMED GUIDE WIRE