K222067 is an FDA 510(k) clearance for the SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Quanta Dialysis Technologies, Ltd. (Alcester, GB). The FDA issued a Cleared decision on November 10, 2022, 120 days after receiving the submission on July 13, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K222067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |