MSF — Hemodialyzer, Re-Use, High Flux Class II

FDA Device Classification

Classification Details

Product Code
MSF
Device Class
Class II
Regulation Number
876.5860
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023615gambro renal productsGAMBRO POLYFLUX 6 LR, 8 LR AND 10 LRMay 6, 2003
K994390gambro healthcareGAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTEROctober 26, 2000
K970679althin medical ab an affiliate of baxter intlALTRA FLUX 200 HEMODIALYZERJuly 23, 1998
K970681althin medical ab an affiliate of baxter intlALTRA NOVA 200 HEMODIALYZERJuly 23, 1998
K970662baxter healthcareCA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)March 11, 1998
K970653baxter healthcareCAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)March 11, 1998
K970663baxter healthcareCT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)January 11, 1998
K970648renal systemsPRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)January 5, 1998