21 CFR § 876.5470 - Ureteral dilator.
§ 876.5470 Ureteral dilator.
(a) Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.
(b) Classification. Class II (performance standards).