510(k) K222067 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
| Applicant | Quanta Dialysis Technologies, Ltd., Alcester, GB |
| Decision | Substantially Equivalent, Nov 10, 2022 |
| Received | Jul 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222067
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.