BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Neonav ECG Tip Location System

    K Number: K260929 · Decision Apr 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    Neonav ECG Tip Location System
    K Number
    K260929
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navi Medical Technologies
    Date Received
    March 20, 2026
    Decision Date
    April 17, 2026
    Product Code
    LJS
    Advisory Committee
    General Hospital
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Navi Medical Technologies

    K Number Device Name
    K241910 Neonav ECG Tip Location System