NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
Device Facts
| Record ID | K953597 |
|---|---|
| Device Name | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER |
| Applicant | Meadox Medicals, Div. Boston Scientific Corp. |
| Product Code | EZN · Gastroenterology, Urology |
| Decision Date | Oct 7, 1995 |
| 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.
