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

    Willow 18 Guidewire

    K Number: K260130 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    39
    Applicant Total
    4
    Review Days
    28

    Basic Information

    Device Name
    Willow 18 Guidewire
    K Number
    K260130
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arbor Endovascular, LLC
    Date Received
    January 16, 2026
    Decision Date
    February 13, 2026
    Product Code
    MOF
    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
    MOF Guide, Wire, Catheter, Neurovasculature

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