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510(k) Data Aggregation

    K Number
    K130304
    Device Name
    LMA FAMILY OF AIRWAYS
    Manufacturer
    THE LARYNGEAL MASK CO.,LTD.
    Date Cleared
    2014-05-30

    (477 days)

    Product Code
    CAE, BTR
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LMA Unique™, LMA Classic™, LMA Classic Excel™, LMA Flexible™, LMA Flexible™ Single Use, LMA ProSeal™, LMA Fastrach™ Single Use, and LMA Supreme™ are devices inserted into a patient's pharynx through the mouth to provide a patent airway. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field. The LMA Fastrach™ ETT (reusable) and LMA Fastrach™ ETT Single Use are indicated for airway management by oral intubation of the trachea. Reinforced ETT may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. These can be used in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.
    Device Description
    The LMA™ family of airways includes 2 types of airways: Generically referred to as supraglottic airways and Tracheal Tubes specific for use with the LMA Fastrach™ device. The supraglottic airways are airways that incorporate a large cuff that sits above the glottic opening and the opposite end has a standard 15 mm OD connector that connector to a gas source. The LMA Flexible™ is the same as the Classic™ except that the shaft is wire reinforced allowing for great flexibility. The LMA ProSeal™ which has a second lumen for drainage. The LMA Fastrach™ single use which has a rigid handle to assist with insertion. The LMA Fastrach™ ETT and LMA Fastrach™ ETT Single Use is straight, cuffed, wire reinforced tracheal tube that is designed to be used with the LMA Fastrach™ supraglottic airway.
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    K Number
    K033189
    Device Name
    KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2004-05-04

    (216 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.
    Device Description
    Tube with two attached, inflatable balloons. Ventilation openings between the balloons. Can be sterilized in an autoclave. Proximal ISO Standard 15mm connector for attachment to breathing circuit. Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. Connected to a Breathing Circuit. Inserted blindly. Seals the esophagus. Cuffs are inflated with one inflation port. Instructions that patient should have fasted before using the product. Latex free product.
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    K Number
    K033186
    Device Name
    KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2004-04-14

    (196 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KING LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
    Device Description
    Each device is constructed of medical grade elastomeric and thermoplastic materials. All fittings conform to ISO 5356-1/1996: Anesthetic and Respiratory Equipment - Conical Connectors; Part 1 Cones and Sockets. The device incorporates the following components or features: - . Bi-directional gas flow through a ventilation channel. - Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere - . Indicators for proper placement permanently printed on the tube - A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.
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    K Number
    K021634
    Device Name
    KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
    Manufacturer
    KING SYSTEMS CORP.
    Date Cleared
    2003-01-09

    (237 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KING LT oropharyngeal airway is intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents.
    Device Description
    Not Found
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    K Number
    K955721
    Device Name
    CUFFED OROPHARYNGEAL AIRWAY (COPA)
    Manufacturer
    MALLINCKRODT MEDICAL
    Date Cleared
    1997-03-28

    (466 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K960240
    Device Name
    RUSCH OPTOSAFE
    Manufacturer
    RUSCH INTL.
    Date Cleared
    1996-04-19

    (94 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rusch Optosafe, sterile, for oral insertion to provide an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivlent in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce. The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation.
    Device Description
    The device consists of a clear, implant tested, PVC tube formed into the conventional hooked shape of an oral airway. The tube is bonded with a polyurethane adhesive to a clear implant tested PVC bite block and flange molding. The flange is printed with the manufacturer's name, date code and size (nominal inner diameter of tube).
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    K Number
    K950613
    Device Name
    KEISEI
    Manufacturer
    KEISEI (USA) CO., LTD.
    Date Cleared
    1996-02-14

    (369 days)

    Product Code
    CAE
    Regulation Number
    868.5110
    Why did this record match?
    Product Code :

    CAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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