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

    XC11 ICE System, USA

    K Number: K250955 · Decision Oct 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    1
    Review Days
    205

    Basic Information

    Device Name
    XC11 ICE System, USA
    K Number
    K250955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yorlabs, Inc.
    Date Received
    March 31, 2025
    Decision Date
    October 22, 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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