510(k) K950454

CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER by Baxter Healthcare Corp — Product Code FJI

K950454 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER". The FDA issued a decision of Substantially Equivalent on Apr 27, 1995. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.