The following data is part of a premarket notification filed by Quanta Dialysis Technologies Ltd with the FDA for Sc+ Hemodialysis Device, Sc+ Dialysate Cartridge, Sc+ Blood Tube Set.
| Device ID | K222067 |
| 510k Number | K222067 |
| Device Name: | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Quanta Dialysis Technologies Ltd Tything Road Alcester, GB B49 6EU |
| Contact | Sam Drew |
| Correspondent | Sam Drew Quanta Dialysis Technologies Ltd Tything Road Alcester, GB B49 6EU |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-13 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060497260167 | K222067 | 000 |
| 05060497260160 | K222067 | 000 |