K221386 is an FDA 510(k) clearance for the PERF-GEN Pulsatile Perfusion Solution. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by Institut Georges Lopez (Lissieu, FR). The FDA issued a Cleared decision on June 14, 2022, 32 days after receiving the submission on May 13, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K221386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2022 |
| Decision Date | June 14, 2022 |
| Days to Decision | 32 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 |