FDA 510(k) Applications for Medical Device Product Code "MSF"
(Hemodialyzer, Re-Use, High Flux)

FDA 510(k) Number Applicant Device Name Decision Date
K970679 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA FLUX 200 HEMODIALYZER 07/23/1998
K970681 ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL ALTRA NOVA 200 HEMODIALYZER 07/23/1998
K970662 BAXTER HEALTHCARE CORP. CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) 03/11/1998
K970653 BAXTER HEALTHCARE CORP. CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) 03/11/1998
K970663 BAXTER HEALTHCARE CORP. CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) 01/11/1998
K994390 GAMBRO HEALTHCARE GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER 10/26/2000
K023615 GAMBRO RENAL PRODUCTS GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR 05/06/2003
K970648 RENAL SYSTEMS, INC. PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) 01/05/1998


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