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

    Medtronic Stedi Extra Support Guidewire

    K Number: K250075 · Decision Jun 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    252
    Registration Numbers
    253
    Same Product Code
    751
    Applicant Total
    8
    Review Days
    154

    Basic Information

    Device Name
    Medtronic Stedi Extra Support Guidewire
    K Number
    K250075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Inc
    Date Received
    January 10, 2025
    Decision Date
    June 13, 2025
    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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