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

    Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

    K Number: K201690 · Decision Jul 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    32
    Review Days
    29

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    Basic Information

    Device Name
    Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
    K Number
    K201690
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    June 22, 2020
    Decision Date
    July 21, 2020
    Product Code
    DQX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    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 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

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