BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System

    K Number: K242893 · Decision Mar 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    2
    Review Days
    182

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    Basic Information

    Device Name
    VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System
    K Number
    K242893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Luma Vision Limited
    Date Received
    September 23, 2024
    Decision Date
    March 24, 2025
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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    Other Clearances by Luma Vision Limited

    K Number Device Name
    K260885 VERAFEYE Imaging and Guidance System (VF-VIS-002)