Panels › Gastroenterology, Urology › Product code MSE · Class 2
Hemodialyzer, Re-Use, Low Flux
Regulation 876.5820
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MSE
| Company | 510(k)s | Recalls |
|---|---|---|
| Asahi Medical Co., Ltd. | 2 | 2 |
| Baxter Healthcare Corp | 3 | 0 |
| Fresenius USA, Inc. | 1 | 0 |
| Fresenius Medical Care North America | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2000 | K001685 | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 Baxter Healthcare Corp | MSE |
| May 17, 1999 | 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- Asahi Medical Co., Ltd. | MSE |
| Sep 15, 1998 | K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX Fresenius USA, Inc. | MSE |
| Aug 27, 1998 | K974090 | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS Fresenius Medical Care North America | MSE |
| Nov 12, 1997 | K970661 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) Baxter Healthcare Corp | MSE |
| Nov 12, 1997 | K970654 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) Baxter Healthcare Corp | MSE |
| Sep 30, 1997 | K970650 | ASAHI AM-R SERIES DIALYZERS Asahi Medical Co., Ltd. | MSE |
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