K121736 is an FDA 510(k) clearance for the PERF-GEN PULSATILE PERFUSION SOLUTION, a Set, Perfusion, Kidney, Disposable (Class II — Special Controls, product code KDL), submitted by Waters Medical Systems, LLC (Rochester, US). The FDA issued a Cleared decision on August 16, 2013, 429 days after receiving the submission on June 13, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K121736 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 13, 2012 |
| Decision Date | August 16, 2013 |
| Days to Decision | 429 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDL — Set, Perfusion, Kidney, Disposable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5880 |