K180481 is an FDA 510(k) clearance for the Servator B SALF Solution. 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 June 29, 2018, 126 days after receiving the submission on February 23, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K180481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2018 |
| Decision Date | June 29, 2018 |
| Days to Decision | 126 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 |