K130804 is an FDA 510(k) clearance for the UROMAX ULTRA BALLOON DILATATION CATHETER. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on May 22, 2013, 58 days after receiving the submission on March 25, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K130804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2013 |
| Decision Date | May 22, 2013 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZN — Dilator, Catheter, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5470 |