K210661 is an FDA 510(k) clearance for the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset. 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 August 12, 2021, 161 days after receiving the submission on March 4, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K210661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2021 |
| Decision Date | August 12, 2021 |
| Days to Decision | 161 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 |