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

    Quantra QStat Cartridge

    K Number: K251404 · Decision Aug 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    111

    Basic Information

    Device Name
    Quantra QStat Cartridge
    K Number
    K251404
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5430
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemosonics, LLC
    Date Received
    May 6, 2025
    Decision Date
    August 25, 2025
    Product Code
    QFR
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties

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