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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.

    AI/ML Overview

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