Panels › Gastroenterology, Urology › Product code MSF · Class 2
Hemodialyzer, Re-Use, High Flux
Regulation 876.5860
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MSF
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 3 | 0 |
| Althin Medical AB an Affiliate of Baxter Intl | 2 | 0 |
| Gambro Healthcare | 1 | 0 |
| Gambro Renal Products | 1 | 0 |
| Renal Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 2003 | K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR Gambro Renal Products | MSF |
| Oct 26, 2000 | K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER Gambro Healthcare | MSF |
| Jul 23, 1998 | K970681 | ALTRA NOVA 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | MSF |
| Jul 23, 1998 | K970679 | ALTRA FLUX 200 HEMODIALYZER Althin Medical AB an Affiliate of Baxter Intl | MSF |
| Mar 11, 1998 | K970662 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) Baxter Healthcare Corp | MSF |
| Mar 11, 1998 | K970653 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) Baxter Healthcare Corp | MSF |
| Jan 11, 1998 | K970663 | CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) Baxter Healthcare Corp | MSF |
| Jan 5, 1998 | K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) Renal Systems, Inc. | MSF |
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