BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

    K Number: K212688 · Decision Jan 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    15
    Review Days
    138

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    Basic Information

    Device Name
    Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
    K Number
    K212688
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qura S.R.L
    Date Received
    August 25, 2021
    Decision Date
    January 10, 2022
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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