Data / Medical devices / United Kingdom / Quanta Dialysis Technologies Ltd
Quanta Dialysis Technologies Ltd: FDA-registered device maker in St Asaph Denbighshire, United Kingdom, 1 510(k) clearance
Quanta Dialysis Technologies Ltd is registered with the FDA (registration 3020689844) in St Asaph Denbighshire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020689844
- Address
- Fford Richard Davies, St Asaph Denbighshire, United Kingdom, LL17 0LJ
- Owner or operator
- Quanta Dialysis Technologies Ltd (10080477)
- Roles
- Manufacturer
- First device listed
- June 16, 2023
- Registered through
- 2026
- Brand names listed
- Bicarbonate Spare Connectors Set, Blood Tube Set, Dialysate Cartridge, Quanta Dialysis System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2022 | K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set | KDI | Substantially Equivalent | Quanta Dialysis Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Updated November 10, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.