Hemodialyzer With Expanded Solute Removal Profile
The Hemodialyzer with Expanded Solute Removal Profile is an advanced dialysis device used as part of an artificial kidney system for patients with renal failure, performing hemodialysis, hemofiltration, and hemodiafiltration with a modified semipermeable membrane that allows increased removal of uremic retention solutes, including solutes in the middle to upper molecular weight range (0.5 kDa to 60 kDa), beyond that of standard high-flux hemodialyzers. It is classified as a Class 2 device under regulation 876.5862, requiring 510(k) premarket notification, and falls within the Gastroenterology/Urology (GU) medical specialty. The product code is QAX. It is flagged as life-sustaining.
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Basic Information
- Product Code
- QAX
- Device Class
- FDA class 2
- Regulation Number
- 876.5862
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Aug 28, 2020 | Unknown | Baxter Healthcare Corporation |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.