K993840 is an FDA 510(k) clearance for the BARD UROFORCE BALLOON DILATION CATHETER. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 31, 2000, 80 days after receiving the submission on November 12, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K993840 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1999 |
| Decision Date | January 31, 2000 |
| Days to Decision | 80 days |
| Submission Type | Abbreviated |
| 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 |