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

    AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

    K Number: K223918 · Decision Jun 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    46
    Review Days
    161

    Basic Information

    Device Name
    AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
    K Number
    K223918
    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
    December 29, 2022
    Decision Date
    June 8, 2023
    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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