VAS-CATH URETERAL STENT CATHETER

K894357 · Vas-Cath, Inc. · FAD · Oct 3, 1989 · Gastroenterology, Urology

Device Facts

Record IDK894357
Device NameVAS-CATH URETERAL STENT CATHETER
ApplicantVas-Cath, Inc.
Product CodeFAD · Gastroenterology, Urology
Decision DateOct 3, 1989
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.4620
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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