K071049 is an FDA 510(k) clearance for the DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR, 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 October 16, 2007, 186 days after receiving the submission on April 13, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K071049 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 13, 2007 |
| Decision Date | October 16, 2007 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |