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510(k) Data Aggregation
K Number
K023019Device Name
VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
Manufacturer
Date Cleared
2002-12-10
(90 days)
Product Code
Regulation Number
876.5130Why 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
K022257Device Name
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
Manufacturer
Date Cleared
2002-10-04
(84 days)
Product Code
Regulation Number
870.1390Why 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
K022318Device Name
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
Manufacturer
Date Cleared
2002-09-19
(73 days)
Product Code
Regulation Number
884.1730Why 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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