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

    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

    K Number: K252541 · Decision Mar 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    6
    Review Days
    212

    Basic Information

    Device Name
    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
    K Number
    K252541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrum Medical S.R.L.
    Date Received
    August 12, 2025
    Decision Date
    March 12, 2026
    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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