K202652 is an FDA 510(k) clearance for the Servator P SALF Solution with THAM. This device is classified as a System, Perfusion, Kidney (Class II - Special Controls, product code KDN).
Submitted by S.A.L.F. Spa (Cenate Sotto, IT). The FDA issued a Cleared decision on August 19, 2021, 339 days after receiving the submission on September 14, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K202652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | August 19, 2021 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDN - System, Perfusion, Kidney |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |