K133615 is an FDA 510(k) clearance for the WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Well Lead Medical Co., Ltd. (Apollo Beach, US). The FDA issued a Cleared decision on February 24, 2014, 91 days after receiving the submission on November 25, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K133615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2013 |
| Decision Date | February 24, 2014 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD - Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |