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

    Sunmed Disposable Angio-Closure Pads

    K Number: K191827 · Decision Mar 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    6
    Review Days
    252

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    Basic Information

    Device Name
    Sunmed Disposable Angio-Closure Pads
    K Number
    K191827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunny Medical Device (Shenzhen) Co., Ltd.
    Date Received
    July 8, 2019
    Decision Date
    March 16, 2020
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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    Other Clearances by Sunny Medical Device (Shenzhen) Co., Ltd.

    K Number Device Name
    K160190 Sunmed Control Syringes
    K153685 Sunmed Haemostatic Valves
    K140356 SUMMED HIGH PRESSURE LINE
    K133795 SUMMED INFLATION DEVICE KIT
    K120119 SUNMED GUIDE WIRE