BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

    K Number: K252645 · Decision Oct 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    104
    Review Days
    64

    Basic Information

    Device Name
    LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
    K Number
    K252645
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems Nederland B.V.
    Date Received
    August 21, 2025
    Decision Date
    October 24, 2025
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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