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

    CentriMag™ Acute Circulatory Support System

    K Number: K234118 · Decision Jan 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    57
    Review Days
    29

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    Basic Information

    Device Name
    CentriMag™ Acute Circulatory Support System
    K Number
    K234118
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ABBOTT MEDICAL
    Date Received
    December 28, 2023
    Decision Date
    January 26, 2024
    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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