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

    CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

    K Number: K222038 · Decision Dec 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    150

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    Basic Information

    Device Name
    CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System
    K Number
    K222038
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott (Formerly Thoratec Corporation)
    Date Received
    July 11, 2022
    Decision Date
    December 8, 2022
    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 Abbott (Formerly Thoratec Corporation)

    K Number Device Name
    K200306 CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit