K190063 is an FDA 510(k) clearance for the Servator C SALF Solution. This device is classified as a System And Accessories, Isolated Heart, Transport And Preservation (Class II - Special Controls, product code MSB).
Submitted by S.A.L.F. Spa (Cenate Sotto, IT). The FDA issued a Cleared decision on August 14, 2019, 211 days after receiving the submission on January 15, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K190063 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2019 |
| Decision Date | August 14, 2019 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSB - System And Accessories, Isolated Heart, Transport And Preservation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5880 |