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

    TELLTALE Electrosurgical Guidewire System

    K Number: K252592 · Decision Nov 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    90

    Basic Information

    Device Name
    TELLTALE Electrosurgical Guidewire System
    K Number
    K252592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1254
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Telltale, LLC
    Date Received
    August 15, 2025
    Decision Date
    November 13, 2025
    Product Code
    SGO
    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
    SGO Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures