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

    Inno-Hydrowire

    K Number: K172187 · Decision Apr 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    252
    Registration Numbers
    253
    Same Product Code
    751
    Applicant Total
    2
    Review Days
    265

    Basic Information

    Device Name
    Inno-Hydrowire
    K Number
    K172187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suzhou Innomed Medical Device Co.,Ltd
    Date Received
    July 20, 2017
    Decision Date
    April 11, 2018
    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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