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510(k) Data Aggregation

    K Number
    K081725
    Device Name
    ENTERAL PUMP SET, MODEL 20-1010
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2008-11-07

    (142 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enteral Pump Set is intended to dispense liquid nutrients from enteral formula containers with SpikeRight™ port via VIASYS MedSystems Enteral Pumps.
    Device Description
    Not Found
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    K Number
    K080679
    Device Name
    MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2008-06-27

    (109 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.
    Device Description
    The CORTRAK™ System is an electrical device.
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    K Number
    K063061
    Device Name
    CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2007-04-02

    (179 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding, Prior to commencing the delivery of food, confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.
    Device Description
    The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding.
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    K Number
    K043044
    Device Name
    ANTI-I.V. ENTERAL FEEDING SYSTEM
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2005-05-06

    (183 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anti-I.V. Enteral Feeding System is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentric route. The Anti-I.V. Enteral Feeding Tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoentic route. The Anti-I.V. Enteral Feeding Extension Set is intended to be connected to the nutritional source to the Anti-I.V. Enteral Feeding Tube. The Anti-I.V. Enteral Feeding System is for pediatric and neonatal use only.
    Device Description
    Not Found
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    K Number
    K050309
    Device Name
    PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2005-03-25

    (45 days)

    Product Code
    CAP
    Regulation Number
    868.2600
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.
    Device Description
    Not Found
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    K Number
    K043004
    Device Name
    STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2005-03-16

    (135 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FreedomAire II Surgical Helmet is intended to be worn by operating room personnel in order to provide a barrier between the operating environment and operating room personnel from in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Device Description
    STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM
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    K Number
    K041987
    Device Name
    CORTRAK
    Manufacturer
    VIASYS MEDSYSTEMS
    Date Cleared
    2004-12-17

    (147 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIASYS MEDSYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of feeding tubes of 8 FF or larger in the stomach or small bowel of patients requiring enteral feeding. Confirmation of correct tube placement by X-ray or acceptable hospital protocol is required.
    Device Description
    Not Found
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