MSE — Hemodialyzer, Re-Use, Low Flux Class II
FDA Device Classification
Classification Details
- Product Code
- MSE
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K001685 | baxter healthcare | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | November 15, 2000 |
| K983720 | asahi medical co | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI | May 17, 1999 |
| K970700 | fresenius usa | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | September 15, 1998 |
| K974090 | fresenius medical care north america | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS | August 27, 1998 |
| K970661 | baxter healthcare | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) | November 12, 1997 |
| K970654 | baxter healthcare | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) | November 12, 1997 |
| K970650 | asahi medical co | ASAHI AM-R SERIES DIALYZERS | September 30, 1997 |