510(k) K970653

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) by Baxter Healthcare Corp — Product Code MSF

K970653 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code MSF (Hemodialyzer, Re-Use, High Flux), a Class II device regulated under 21 CFR 876.5860. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.