DILATOR/SHEATH SET
Device Facts
| Record ID | K842632 |
|---|---|
| Device Name | DILATOR/SHEATH SET |
| Applicant | American Edwards Laboratories |
| Product Code | EZN · Gastroenterology, Urology |
| Decision Date | Oct 2, 1984 |
| 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.
