K033719 is an FDA 510(k) clearance for the BARD TIGERTAIL URETERAL CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on February 4, 2004, 70 days after receiving the submission on November 26, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K033719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2003 |
| Decision Date | February 04, 2004 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |