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510(k) Data Aggregation

    K Number
    K954258
    Device Name
    TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
    Manufacturer
    GERARD MEDICAL ENTERPRISES, INC.
    Date Cleared
    1996-05-24

    (262 days)

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

    GERARD MEDICAL ENTERPRISES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.
    Device Description
    The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.
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