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510(k) Data Aggregation

    K Number
    K252541

    Validate with FDA (Live)

    Device Name
    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
    Manufacturer
    Spectrum Medical S.R.L.
    Date Cleared
    2026-03-12

    (212 days)

    Product Code
    DTR
    Regulation Number
    870.4240
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K223879,K202206
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K223879

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 3.0 l/min.

    Device is intended for pediatric patients (BSA according following characteristics: 0.6 m2 < BSA < 1m2).

    Device Description

    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours.

    The device is designed to:

    • keep circulating blood at a specific temperature, depending on the type of surgery being performed;
    • maintain blood/patient thermoregulation during the CPB;
    • rewarm blood at the conclusion of the CPB in order to restore normothermic patient condition.

    Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W has been designed to be powered by heater-cooler systems that use

    • Water, or
    • Glycol-based solution

    as Heat Transfer Fluid (HTF).

    AI/ML Overview

    N/A

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