K003289 is an FDA 510(k) clearance for the BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED). This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 5, 2001, 77 days after receiving the submission on October 20, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K003289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2000 |
| Decision Date | January 05, 2001 |
| Days to Decision | 77 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |