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510(k) Data Aggregation

    K Number
    K221827
    Device Name
    Mais Central Venous Catheter
    Date Cleared
    2023-06-23

    (365 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Saudi Mais Co. for Medical Products

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Mais central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and central venous pressure monitoring.
    Device Description
    Mais Central Venous Catheter is a radio opaque catheter, which is placed mainly in the subclavian, or jugular veins down to the right auricle as a short-term channeling access to the central venous system for central administration of drugs and central infusion of fluids and transfusion of blood. The device provides pre-operative access to infuse anesthesia drugs and quick central access in emergencies as cardiac standstill, shock, etc. Measuring the central venous pressure can be achieved by connecting the central lumen to the measuring device tube. Central venous (CV) catheters can be used in anesthesia, critical care, and emergency medicine. The correct positioning of the central venous catheter is of key significance for therapeutic success. For most applications, placement in the superior vena cava approximately 2cm before the opening into the right atrium is viewed as the optimal position for the catheter tip. The CV Catheter is needle punctured and surgically inserted into the superior vena cava (a large vein) of a patient. It can be planted inside for one-month maximum. Mais Catheters are made from soft polyurethane material and have double, triple or quadruple lumens, and the length is variable. The Mais catheter consists of a white radio opaque multi lumen tube which is tipped with a soft polyurethane material and has many side holes relevant to each lumen. There are markings along the effective length to indicate each centimeter. There is a connector which connects the catheter lumen(s) to a lumen of a transparent polyurethane extension tube so each catheter lumen is connected to a specific extension line. The connector is polyurethane and nearly triangular shaped. Each extension tube is marked to indicate which catheter lumen is attached to it. Distal lumen is used for the CVP monitoring. A flat clamp is put over each extension tube. The flat clamp is colored differently for a given multi lumen catheter.
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