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510(k) Data Aggregation

    K Number
    K043178
    Device Name
    GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
    Date Cleared
    2006-02-02

    (443 days)

    Product Code
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRANTADLER CORPORTATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The grantAdler Rhapsody Access Port and Catheter is indicated for any patient requiring reliable repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood. blood products or the sampling of blood.
    Device Description
    The grantAdler Implantable Access Ports are implantable ports for intraveneous injections. The grantAdler Implantable Access Ports are supplied as sterile devices, and are intended for single patient use only. The ports are available as a single model and are manufactured of the highest quality titanium. They also incorporate a durable high compression self-sealing silicone septum. Catheter materials include flexible, noncompressible, and reinforced silicone. Suture sites are incorporated into the port base to facilitate anchorage to the underlying fascia.
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