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510(k) Data Aggregation

    K Number
    K063469
    Device Name
    MEDICAN ALPHA
    Date Cleared
    2006-12-01

    (15 days)

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

    EASTERN MEDIKIT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intravascular catheter is a medical device intended to be used to introduce fluids or medicament through the peripheral veins and / or withdrawal of blood samples. Intravascular catheter comprises of a short flexible plastic tube (the Catheter) which is inserted into a vein over a hollow introducer needle, after which the needle is withdrawn and discarded. The intravascular catheter is used in aseptic environment. Federal law (USA) restricts this device to sale by or on the order of a physician. - Infusion of I.V. Solutions. - Intermittent intravenous Drug administration.
    Device Description
    As per ISO 10555-1, the generic definition of an intravascular catheter is - Intravascular catheter is a tubular device, single or multi lumen, designed to be partially or totally inserted into the cardiovascular system for diagnostic and/or therapeutic purpose The device under this submission is an over-needle-peripheral catheter. Over - the - needle peripheral intravascular catheters are intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use. These catheters are designed for the introduction or withdrawal of liquids into or from the peripheral vascular system.
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