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

    VitalFlow Console

    K Number: K250199 · Decision May 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    209
    Review Days
    117

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    Basic Information

    Device Name
    VitalFlow Console
    K Number
    K250199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    January 23, 2025
    Decision Date
    May 20, 2025
    Product Code
    QNR
    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
    QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

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