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510(k) Data Aggregation

    K Number
    K030636
    Device Name
    C-PORT
    Manufacturer
    CLINISURG VASCULAR PRODUCTS, LLC
    Date Cleared
    2003-06-05

    (97 days)

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

    CLINISURG VASCULAR PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-Port family of products will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, nutritional solutions and blood products or withdrawal of blood.
    Device Description
    The CliniSurg family of Vascular Access devices is a group of subcutaneously implantable ports with a catheter either pre-attached or attachable for application by physicians in indicated therapies. The device has a port that is a titanium chamber with a silicone membrane designed for repeated needle insertion. The port comes in various sizes to enable use with larger adults or smaller pediatric patients or the more emaciated adult patient. A higher or lower profile device is chosen by patient evaluation. The port is connected to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into larger vessels. The catheter is fixed to the port with a hub either during a procedure to implant the device or it comes pre-assembled (physician choice for use). The catheter has a series of radiopaque marks to enable depth determination when the catheter is inserted into the vena cava. A kit is provided to aid in catheter placement, insertion, and port implantation. Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit.
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