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510(k) Data Aggregation

    K Number
    K250821
    Device Name
    Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
    Manufacturer
    Eurosets Srl
    Date Cleared
    2025-12-12

    (269 days)

    Product Code
    DTZ,DTM,DTN,DTR
    Regulation Number
    870.4350
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K242503
    Device Name
    Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
    Manufacturer
    Eurosets Srl
    Date Cleared
    2025-11-24

    (459 days)

    Product Code
    DTZ,DTM,DTN,DTR
    Regulation Number
    870.4350
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K151389
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

    The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

    The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is compromised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 2.5-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post-Operative Chest Drainage Procedures.

    Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir is for use with patients when the required blood flow will not exceed 3.5 L/min and within a BSA range of 1.28 to 1.46.

    Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir can be used in procedures lasting up to 6 hours.

    Device Description

    The TRILLY OXYGENATOR with Integrated Arterial Filter and Hardshell Reservoir ("Trilly AF") is a microporous hollow-fibre membrane oxygenator consisting of a gas exchange module with an integrated heat exchanger and an integrated 38μm arterial filter that ensures arterial blood filtration and facilitates air removal from emboli.

    The device also has a hard-shell cardiotomy/venous reservoir (CVR) that can be connected to the aspirators, designed to allow venous drainage of the patient's blood, making it both the hydrostatic load offered by the difference in height between the patient and the reservoir and the vacuum-assisted technique (VAVD).

    The device hard-shell cardiotomy/venous reservoir is fitted with a pressure relief valve.

    The device inner contact surfaces are coated with A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) system, based on Phosphorylcholine (PC). The A.G.I.L.E. coating doesn't have any biological activity.

    The device is single use, non-pyrogenic, supplied sterile and individually packed. It is sterilized by ethylene oxide.

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