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510(k) Data Aggregation

    K Number
    K130131
    Device Name
    EDRAIN CHEST DRAINAGE SYSTEM
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2013-02-28

    (41 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Evacuate air and/or fluid from the chest cavity or mediastinum
    Help re-establish lung expansion and restore breathing dynamics
    Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the "Atrium eDrain Chest Drainage System." It does not contain information about acceptance criteria, device performance, study details, ground truth, or sample sizes for an AI/ML powered device. The letter is a regulatory document confirming clearance for a traditional medical device (a powered suction pump) and references general manufacturing and labeling requirements.

    Therefore, I cannot extract the requested information from this document.

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