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510(k) Data Aggregation

    K Number
    K090258
    Device Name
    VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
    Manufacturer
    TALLEY MEDICAL
    Date Cleared
    2009-08-25

    (204 days)

    Product Code
    OMP, BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    TALLEY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Venturi™ NPWT v.II Advanced Vacuum System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patient's bedside.
    Device Description
    The Talley Venturi™ system consists of a powered suction pump for the application of vacuum for fluid removal. Consumables for use with the pump include collection canister and connection tubing.
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    K Number
    K080897
    Device Name
    VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    Manufacturer
    TALLEY MEDICAL
    Date Cleared
    2008-07-15

    (106 days)

    Product Code
    OMP, JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    TALLEY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Venturi™ Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of neqative pressure therapy and the potential wound healing effects of removal of fluids including wound exudates, irrigation fluids, and infectious materials. Venturi is intended for use in acute care settings only.
    Device Description
    The Talley Venturi™ system consists of a powered suction pump for the application of vacuum to wounds for fluid removal. Consumables for use with the pump include collection canister, connection tubing, drain, and wound dressing products.
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    K Number
    K080763
    Device Name
    TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
    Manufacturer
    TALLEY MEDICAL
    Date Cleared
    2008-05-30

    (73 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    TALLEY MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Talley TableGard Pressure Relieving Patient Warming Mattress is indicated for use for patients that may be benefited by the application of heat during surgical procedures to help maintain normothermia. It is intended for use in the operating rooms, recovery rooms, intensive care departments, emergency rooms in hospitals and outpatient clinics to assist patients to maintain normal body temperature. The TableGard mattress also includes alternating air support to relieve pressure against soft tissues during prolonged periods of immobilization.
    Device Description
    The TableGard Pressure Relieving Patient Warming Mattress system consists of an alternating air mattress (patient support surface) with air pump, and a connectable and thermally regulated warm air blower unit. The air mattress is enclosed in a vinyl and polyurethane cover, which is in turn fitted with air inlet and outlet ports to receive and recirculate warmed air within the air mattress cover under the patient. The patient is warmed by conduction of heat (regulated between 34° and 40° C) thru the polyurethane cover. The air pump and air blower unit operate on 110V, but there is no electrical contact between the control devices and the patient support mattress. The air pump alternately cycles pressures between sections of the mattress to relieve interface pressure against the patient's soft tissues.
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