K170150 is an FDA 510(k) clearance for the Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags. This device is classified as a Set, Perfusion, Kidney, Disposable (Class II - Special Controls, product code KDL).
Submitted by S.A.L.F. Spa (Cenate Sotto, IT). The FDA issued a Cleared decision on October 20, 2017, 276 days after receiving the submission on January 17, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5880.
| 510(k) Number | K170150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2017 |
| Decision Date | October 20, 2017 |
| Days to Decision | 276 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 |