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The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedure up to 6 hours in duration. Devices are intended for adult patients.

The subject of the present Special 510(k) is the Quantum PureFlow Standard Heat Exchanger product family for inclusion of three additional variants with respect to the currently cleared (K220110) portfolio. Quantum PureFlow Standard Heat Exchanger devices are designed to manage the temperature of blood during surgical procedures requiring cardiopulmonary bypass (CPB) for periods lasting less than 6 hours. HX-S devices are 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 Exchangers have been designed to be powered by heatercooler systems that use - Water or - Glycol-based solution as Heat Transfer Fluid (HTF).