K903813 is an FDA 510(k) clearance for the URETERAL BALLOON DILATATION CATHETER. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 7, 1990, 79 days after receiving the submission on August 20, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K903813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1990 |
| Decision Date | November 07, 1990 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EZN — Dilator, Catheter, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5470 |