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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?
    Applicant Name (Manufacturer) :

    **VOMED VOLZER MEDIZINTECHNIK GMBH **& CO

    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
    K022257
    Device Name
    VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
    Date Cleared
    2002-10-04

    (84 days)

    Product Code
    Regulation Number
    870.1390
    Why did this record match?
    Applicant Name (Manufacturer) :

    **VOMED VOLZER MEDIZINTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VOMED trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. VOMED trocars and trocar sleeves then allow endoscopic instruments, thoracoscopes, laparoscopes, a tube or a channel, and accessory devices to be inserted and used during cardiac surgery procedures. VOMED adapters, tube connectors, caps and plugs, stopcocks and valves are noninvasive, reusable devices for use in cardiovascular applications to interconnect tubing and other devices during extracorporeal bypass procedures, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.
    Device Description
    VOMED Trocars and Adapters, Connectors, Stopcocks and Manifolds
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    K Number
    K022318
    Device Name
    VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
    Date Cleared
    2002-09-19

    (73 days)

    Product Code
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    **VOMED VOLZER MEDIZINTECHNIK GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators to blow gas or powder into a tube, cavity, or organ. They are generally used as accessories to devices that provide access, illumination and visualization of internal structures and for manipulating soft tissuc. The devices are indicated for therapeutic and diagnostic laparoscopic and urological procedures. VOMED suction and irrigation tubes and handles are reusable accessories designed for the suction of fluids from wounds and body cavities and/or the irrigation of surgical sites. They are general accessories of devices that provide access, illumination and visualization of internal structures and for manipulating soft tissue. The suction and irrigation devices are indicated for therapeutic laparoscopic and urologic procedures.
    Device Description
    VOMED insufflation needles are reusable devices for temporary use in conjunction with FDA-cleared insufflators. VOMED suction and irrigation tubes and handles are reusable accessories.
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