K042709 is an FDA 510(k) clearance for the DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Tyco Healthcare (Mansfield, US). The FDA issued a Cleared decision on January 18, 2005, 110 days after receiving the submission on September 30, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K042709 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2004 |
| Decision Date | January 18, 2005 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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 |