MSE
7 FDA 510(k) clearances · Product code
264 daysmedian time to decision
567 days90th percentile
7clearances measured
FDA profile
- Official device name
- Hemodialyzer, Re-Use, Low Flux
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1998: 2 · 2003: 27 · 2005: 4 · 2010: 6 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (K001685) | Baxter Healthcare Corp | 2000-11-15 |
| 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- (K983720) | Asahi Medical Co., Ltd. | 1999-05-17 |
| FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (K970700) | Fresenius USA, Inc. | 1998-09-15 |
| 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (K974090) | Fresenius Medical Care North America | 1998-08-27 |
| CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (K970661) | Baxter Healthcare Corp | 1997-11-12 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970654) | Baxter Healthcare Corp | 1997-11-12 |
| ASAHI AM-R SERIES DIALYZERS (K970650) | Asahi Medical Co., Ltd. | 1997-09-30 |
Track MSE automatically
Every clearance here is in the API, with alerts when new ones post.