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510(k) Data Aggregation

    K Number
    K021044
    Device Name
    MADETT
    Manufacturer
    WOLFE TORY MEDICAL, INC.
    Date Cleared
    2002-09-11

    (163 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOLFE TORY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway. To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
    Device Description
    The Endotracheal Mucosal Atomization Device (MADett) is a disposable, sterile device that converts a topical solution into a fine particle spray for application into the trachea bevond the ETT. The clinician connects the device in line between the endotracheal tube and the ventilation device. The clinician then attaches a syringe of topical medication to the luer lock fitting of the atomizer and delivers medications into the trachea while simultaneously ventilating the patient.
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    K Number
    K002255
    Device Name
    LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
    Manufacturer
    WOLFE TORY MEDICAL, INC.
    Date Cleared
    2000-09-18

    (55 days)

    Product Code
    CCT
    Regulation Number
    868.5170
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOLFE TORY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990556
    Device Name
    ESOPHAGEAL INTUBATION DETECTOR
    Manufacturer
    WOLFE TORY MEDICAL, INC.
    Date Cleared
    1999-03-26

    (32 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOLFE TORY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.
    Device Description
    A device that relies on anatomical differences between the trachea and the esophagus. By applying negative pressure to the endotracheal tube, the rigid trachea remains open allowing free aspiration of air into the EDD, whereas the fibromuscular esophagus collapses around the endotracheal tube and thus prevents aspiration of air.
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