Hemodialyzer, Re-Use, Low Flux
A Low Flux Reusable Hemodialyzer is a dialysis membrane device with lower permeability used to filter waste products and excess fluids from the blood of patients with renal failure, and is designed to be reprocessed and reused across multiple dialysis sessions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is designated as a life-sustaining device given its role in supporting patients with kidney failure. The product code is MSE, regulated under 21 CFR 876.5820, within the Gastroenterology and Urology specialty.
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Basic Information
- Product Code
- MSE
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K001685 | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | Nov 15, 2000 | Substantially Equivalent | Baxter Healthcare Corp |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- | May 17, 1999 | Substantially Equivalent | Asahi Medical Co., Ltd. |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Sep 15, 1998 | Substantially Equivalent | Fresenius USA, Inc. |
| K974090 | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS | Aug 27, 1998 | Substantially Equivalent | Fresenius Medical Care North America |
| K970661 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) | Nov 12, 1997 | Substantially Equivalent | Baxter Healthcare Corp |
| K970654 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | Nov 12, 1997 | Substantially Equivalent | Baxter Healthcare Corp |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Sep 30, 1997 | Substantially Equivalent | Asahi Medical Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.