Hemodialyzer With Expanded Solute Removal Profile
- US Product Code (FDA)
- QAXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.5862View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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).
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Hemodialyzer With Expanded Solute Removal Profile is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.