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510(k) Data Aggregation

    K Number
    K980336
    Device Name
    IV STANDS
    Manufacturer
    CLINTON INDUSTRIES, INC.
    Date Cleared
    1998-04-06

    (68 days)

    Product Code
    FOX
    Regulation Number
    880.6990
    Why did this record match?
    Product Code :

    FOX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IV Stands and accessories are intended for hanging IV and other solution bags which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care.
    Device Description
    The Clinton Industries, Inc. IV Stands consist of a series of poles that are affixed to a base. The poles can telescope to various heights. The bases come in various sizes, depending on the pole used. The IV Stands are purchased with hooks for holding IV or other solution bags. The are either 2 or 4 hooks that are affixed to the top of the poles. The IV poles are chrome-plated steel. Each IV Stand consists of two poles with one fitting inside the other and telescoping to various heights. The telescoping portion of the poles is held in place by either a twist lock design or a compression knob. The bases are steel or aluminum with various coatings. Casters are affixed to the bases for movement of the stands. The following accessories are marketed with the IV Stands: Guidance Handle, Drainage Bag Hook, Utility Console Tray, Dual Pump Holder, Multi-pump Holder.
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    K Number
    K964782
    Device Name
    MEDRAD CONTRAST HOLDER
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    1997-02-25

    (90 days)

    Product Code
    FOX
    Regulation Number
    880.6990
    Why did this record match?
    Product Code :

    FOX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medrad Contrast Holders are an accessory device intended to be used in conjunction with Medrad injectors. The device is designed to aid in the transfer of common contrast media or flushing agents such as saline to the syringe. Users of this device are to be medical professionals trained in CT, MR .Angiographic Procedures, and are expected to have a good understanding of the events leading up to and including the use of the device. The Medrad Contrast Holder replaces the need for a separate contrast holder or Medrad Contrast Holder and is designed specifically for use with Medrad injectors.
    Device Description
    The Medrad Contrast Holder will be used in conjunction with 510 (k) approved Medrad Injector systems. The Contrast Holder mounts to either a Medrad injector pedestal or the Counterpoise System ( CS) by means of clamps that attach to the pedestal or CS. The injector pedestal mounted Contrast Holder utilizes a two-section telescoping tube with a hand-turned knob to adjust the height. Two hooks are used to hang containers. One of the pedestal mounts uses two ring clamps to mount to the pedestal shaft. The other mounts to one of the pedestal legs and is supported by a clamp on the handle of the injector control unit. The Contrast Holder for the CS uses a ring clamp to attach to the articulating counterbalance arm of the CS. A hook hangs vertically from the clamp. An optional tray for holding accessories or bottles is available. The tray snaps into a clamp on the lower section of the telescoping tube and can be removed for cleaning.
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    K Number
    K961470
    Device Name
    PORT-A-POLE
    Manufacturer
    PRINS MEDICAL IND., INC.
    Date Cleared
    1996-07-22

    (96 days)

    Product Code
    FOX
    Regulation Number
    880.6990
    Why did this record match?
    Product Code :

    FOX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960027
    Device Name
    HIGH VOLUME I.V. & IRRIGATION TOWER
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-03-12

    (70 days)

    Product Code
    FOX
    Regulation Number
    880.6990
    Why did this record match?
    Product Code :

    FOX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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