BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    CPS COURIER GUIDEWIRE

    K Number: K073082 · Decision Jan 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    7
    Review Days
    69

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    Basic Information

    Device Name
    CPS COURIER GUIDEWIRE
    K Number
    K073082
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brivant, Ltd.
    Date Received
    November 1, 2007
    Decision Date
    January 9, 2008
    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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