URETHRAL AND URETERAL BALLOON DILATATORS
Device Facts
| Record ID | K884711 |
|---|---|
| Device Name | URETHRAL AND URETERAL BALLOON DILATATORS |
| Applicant | Primrose Medical, Inc. |
| Product Code | EZN · Gastroenterology, Urology |
| Decision Date | Sep 29, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5470 |
| Device Class | Class 2 |
Regulatory Classification
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.
