K063795 is an FDA 510(k) clearance for the GUARDIANCATHETER-URINARY DRAINAGE CATHETER, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by Marian Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on March 5, 2007, 73 days after receiving the submission on December 22, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K063795 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 22, 2006 |
| Decision Date | March 05, 2007 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |