MSF
8 FDA 510(k) clearances · Product code
383 daysmedian time to decision
514 days90th percentile
8clearances measured
FDA profile
- Official device name
- Hemodialyzer, Re-Use, High Flux
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2004: 2 · 2006: 22 · 2007: 509 · 2008: 659 · 2010: 5 · 2011: 16
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 |
|---|---|---|
| GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (K023615) | Gambro Renal Products | 2003-05-06 |
| GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (K994390) | Gambro Healthcare | 2000-10-26 |
| ALTRA NOVA 200 HEMODIALYZER (K970681) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| ALTRA FLUX 200 HEMODIALYZER (K970679) | Althin Medical AB an Affiliate of Baxter Intl | 1998-07-23 |
| CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970653) | Baxter Healthcare Corp | 1998-03-11 |
| CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (K970662) | Baxter Healthcare Corp | 1998-03-11 |
| CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (K970663) | Baxter Healthcare Corp | 1998-01-11 |
| PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648) | Renal Systems, Inc. | 1998-01-05 |
Track MSF automatically
Every clearance here is in the API, with alerts when new ones post.