BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Essenz HLM

    K Number: K221373 · Decision Mar 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    51
    Applicant Total
    7
    Review Days
    301

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    Basic Information

    Device Name
    Essenz HLM
    K Number
    K221373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Livanova Deutschland, GmbH
    Date Received
    May 12, 2022
    Decision Date
    March 9, 2023
    Product Code
    DTQ
    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
    DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

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