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

    Hydrophilic Coating Guide Wire

    K Number: K193653 · Decision Aug 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    3
    Review Days
    240

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    Basic Information

    Device Name
    Hydrophilic Coating Guide Wire
    K Number
    K193653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Hengrui Disheng Medical Co., Ltd.
    Date Received
    December 30, 2019
    Decision Date
    August 26, 2020
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Suzhou Hengrui Disheng Medical Co., Ltd.

    K Number Device Name
    K193647 Superpipe Angiographic Catheter
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