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510(k) Data Aggregation

    K Number
    K972859
    Device Name
    FLUTTER D
    Manufacturer
    BRADSTREET CLINICAL RESEARCH ASSOC., INC.
    Date Cleared
    1998-06-05

    (305 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRADSTREET CLINICAL RESEARCH ASSOC., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The efficacy of the Flutter®D as a mucus clearance device for cystic fibrosis patients is based on its ability to 1) vibrate the airways (which loosens mucus from the airway walls), 2) intermittently increase endobronchial pressure (to maintain the patency of airways during exhalation, so that mucus does not become trapped as it moves up the airways), and 3) accelerate expiratory airflow (to facilitate the upward movement of mucus through the airways so that it can be more easily coughed out). Flutter D may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis and in conjunction with a medical need for Positive Expiratory Pressure (PEP) Therapy.
    Device Description
    The Flutter®D is a small hand held device consisting of a hardened plastic mouthpiece at one end, a plastic cover with an opening at the other end, and a valve on the inside created by a high density steel ball resting in a plastic circular cone. The Flutter®D is an expiration resisting device that delivers internal vibrations to patients' airways. The moveable ball inside the Flutter®D opposes the patient's exhaled air, creating a resistance to his expiration due to the weight of the steel ball. The vibrations cause an oscillation effect down in the smallest airway passages within the lungs. With repeated vibrations, mucus secretions are mobilized from deep within the lungs to the throat where they can be huffed up and expectorated.
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