21 CFR 876.5470 — Dilator, Catheter, Ureteral

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5470

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
EZNDilator, Catheter, Ureteral2563rd Party
Innolitics

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