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

    VitalFlowTM Centrifugal Pump

    K Number: K223898 · Decision Aug 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    240

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    Basic Information

    Device Name
    VitalFlowTM Centrifugal Pump
    K Number
    K223898
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
    Date Received
    December 28, 2022
    Decision Date
    August 25, 2023
    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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    Other Clearances by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

    K Number Device Name
    K230364 VitalFlow™ Console