510(k) K970679

ALTRA FLUX 200 HEMODIALYZER by Althin Medical AB an Affiliate of Baxter Intl — Product Code MSF

K970679 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "ALTRA FLUX 200 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on July 23, 1998. The device falls under product code MSF (Hemodialyzer, Re-Use, High Flux), a Class II device regulated under 21 CFR 876.5860. Althin Medical AB an Affiliate of Baxter Intl has at least 10 other 510(k) clearances on record.