510(k) DEN190042
DEN190042 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer". The FDA issued a decision of De Novo Granted on August 28, 2020. The device falls under product code QAX (Hemodialyzer With Expanded Solute Removal Profile), a Class II device regulated under 21 CFR 876.5862. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 28, 2020
- Date Received
- September 16, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemodialyzer With Expanded Solute Removal Profile
- Device Class
- Class II
- Regulation Number
- 876.5862
- Review Panel
- GU
- Submission Type
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).