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

    JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

    K Number: K180795 · Decision Apr 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    58
    Review Days
    16

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    Basic Information

    Device Name
    JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
    K Number
    K180795
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific
    Date Received
    March 27, 2018
    Decision Date
    April 12, 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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