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510(k) Data Aggregation

    K Number
    K250821

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-12

    (269 days)

    Product Code
    Regulation Number
    870.4350
    Age Range
    22 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HORIZON AF Plus is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. HORIZON AF Plus integrated arterial filter provides additional protection against air and solid emboli.

    HORIZON AF Plus is intended to be used for 6 hours or less.

    Device Description

    The HORIZON AF PLUS System (Model number: US5300) is composed of the HORIZON ADULT OXYGENATOR with Integrated Arterial Filter Plus (A.L. One AF Plus) and the Horizon cardiotomy/venous reservoir (CVR).

    The HORIZON ADULT OXYGENATOR with Integrated Arterial Filter Plus 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 with removal of microaggregates and microemboli.

    HORIZON AF PLUS also has a hard-shell cardiotomy/venous reservoir (CVR) integrated with two cardiotomy filters, designed to allow venous drainage of the patient's blood, both through the hydrostatic load (height difference between the patient and the reservoir) and the vacuum-assisted venous drainage (VAVD) technique.

    HORIZON AF PLUS inner contact surfaces are coated with A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.) system, based on Phosphorylcoline (PC).

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

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    K Number
    K242503

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-24

    (459 days)

    Product Code
    Regulation Number
    870.4350
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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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