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510(k) Data Aggregation

    K Number
    K955121
    Manufacturer
    Date Cleared
    1996-05-10

    (183 days)

    Product Code
    Regulation Number
    870.4210
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Use of the endoarterial return cannula is indicated for patients undergoing endovascular cardiopulmonary bypass. The endoarterial return cannula serves to deliver oxygenated blood for cardiopulmonary bypass during cardiac surgery and to allow hemostatic introduction, removal and securing of the endoaortic clamp catheter into the femoral artery.

    Device Description

    This post-enactment device is an extracorporeal cannula used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment.

    AI/ML Overview

    This document does not contain an AI/ML device, therefore, the requested information elements cannot be extracted.

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