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

    Versus™ Catheter (VS110-9NB)

    K Number: K260149 · Decision Feb 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    28

    Basic Information

    Device Name
    Versus™ Catheter (VS110-9NB)
    K Number
    K260149
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liquet Medical, Inc.
    Date Received
    January 20, 2026
    Decision Date
    February 17, 2026
    Product Code
    QEY
    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
    QEY Mechanical Thrombolysis Catheter

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