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510(k) Data Aggregation

    K Number
    K023019
    Device Name
    VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
    Date Cleared
    2002-12-10

    (90 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    FGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. With the aid of a ureterocystoscope, a radiopaque medium is injected into the ureter for radiologic imaging. The VOMED urethra olives are accessories of male urethrographic catheters. They are placed temporarily on the external end of the penis to guide the insertion of the catheters and to facilitate the injection of the opaque substance. The devices are indicated for diagnostic and therapeutic urologic procedures.
    Device Description
    VOMED urethra olives are acorn-tipped reusable devices designed for use in ureterography. They are accessories of male urethrographic catheters.
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    K Number
    K013360
    Device Name
    DFINER UROLOGICAL CATHETER
    Date Cleared
    2002-02-20

    (133 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    FGI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.
    Device Description
    The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.
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