K Number
K010002Device Name
CONTOUR POLARIS URETERAL STENT
Manufacturer
Date Cleared
2001-01-22
(20 days)
Product Code
Regulation Number
876.4620AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
N/A