Hemodialyzer, Re-Use, High Flux
A High Flux Reusable Hemodialyzer is a dialysis membrane device with higher permeability that more effectively removes larger molecular weight uremic toxins, including beta-2 microglobulin, from the blood of patients with end-stage renal disease, and is designed for reprocessing between sessions. It is FDA Class 2, requiring 510(k) clearance, and is a life-sustaining device. The product code is MSF, regulated under 21 CFR 876.5860, reviewed by the Gastroenterology and Urology panel.
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Basic Information
- Product Code
- MSF
- Device Class
- FDA class 2
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR | May 06, 2003 | Substantially Equivalent | Gambro Renal Products |
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | Oct 26, 2000 | Substantially Equivalent | Gambro Healthcare |
| K970681 | ALTRA NOVA 200 HEMODIALYZER | Jul 23, 1998 | Substantially Equivalent | Althin Medical AB an Affiliate of Baxter Intl |
| K970679 | ALTRA FLUX 200 HEMODIALYZER | Jul 23, 1998 | Substantially Equivalent | Althin Medical AB an Affiliate of Baxter Intl |
| K970662 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) | Mar 11, 1998 | Substantially Equivalent | Baxter Healthcare Corp |
| K970653 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | Mar 11, 1998 | Substantially Equivalent | Baxter Healthcare Corp |
| K970663 | CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) | Jan 11, 1998 | Substantially Equivalent | Baxter Healthcare Corp |
| K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) | Jan 05, 1998 | Substantially Equivalent | Renal Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.