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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?
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
K013360Device Name
DFINER UROLOGICAL CATHETER
Manufacturer
Date Cleared
2002-02-20
(133 days)
Product Code
Regulation Number
876.5130Why 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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