K964690 is an FDA 510(k) clearance for the LIBERTY VALVE, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Cleveland Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 21, 1997, 119 days after receiving the submission on November 22, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K964690 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 1996 |
| Decision Date | March 21, 1997 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5250 |