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510(k) Data Aggregation

    K Number
    K112565
    Device Name
    NOVAPORT ONE VASCULAR ACCESS CANNULA
    Manufacturer
    NOVALUNG GMBH
    Date Cleared
    2011-12-06

    (95 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVALUNG GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to < 6 hours.
    Device Description
    The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body. The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass. All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides. NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.
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    K Number
    K072362
    Device Name
    NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
    Manufacturer
    NOVALUNG GMBH
    Date Cleared
    2007-10-23

    (62 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVALUNG GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is intended to be used for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
    Device Description
    The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is a sterile device for single use only and it is not intended to be resterilized by the user. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ is used to deliver oxygen into the blood and remove carbon dioxide from the blood. It is intended to be used as a component in an extracorporeal circuit for patients undergoing cardiopulmonary bypass. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ incorporates a solid surface hollow polymethylpentene (PMP) fiber membrane and has a 1.3 m² surface area. The Novalung® surgical Lung Assist (sLA) Membrane Lung™ has a nominal flow range from 0.5 L/min. to 4.5 L/min and is suitable for patients weighing >20kg.
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