ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
Device Facts
| Record ID | K915392 |
|---|---|
| Device Name | ACCENT DG BALLOON URTERAL DILATOR SET, 10CM |
| Applicant | Cook Urological, Inc. |
| Product Code | EZN · Gastroenterology, Urology |
| Decision Date | Mar 18, 1992 |
| 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.
