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

    CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

    K Number: K120298 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    10
    Review Days
    98

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    Basic Information

    Device Name
    CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
    K Number
    K120298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St. Jude Medical, Cardiac Rhythm Management Divisi
    Date Received
    January 31, 2012
    Decision Date
    May 8, 2012
    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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