QAX — Hemodialyzer With Expanded Solute Removal Profile Class II
FDA product code QAX covers "Hemodialyzer With Expanded Solute Removal Profile", a Class II medical device regulated under 21 CFR 876.5862. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QAX
- Device Class
- Class II
- Regulation Number
- 876.5862
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A hemodialyzer with expanded solute removal profile is intended for use as part of an artificial kidney system for the treatment of patients with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal of uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification (21 CFR §876.5860), including solutes at the upper end of the middle molecular weight range (0.5 kDa to 60 kDa).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190042 | baxter healthcare corporation | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | August 28, 2020 |