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

    NITREX NITINOL GUIDEWIRE

    K Number: K031864 · Decision Jun 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    5
    Review Days
    8

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    Basic Information

    Device Name
    NITREX NITINOL GUIDEWIRE
    K Number
    K031864
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ev3 Corporation
    Date Received
    June 16, 2003
    Decision Date
    June 24, 2003
    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 Ev3 Corporation

    K Number Device Name
    K051379 PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
    K050725 PROTEGE GPS SELF-EXPANDING NITINOL STENT
    K021096 X-SIZER CATHETER SYSTEM
    K024021 NITREX NITINOL GUIDEWIRE