510(k) K950522

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

K950522 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 KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Baxter Healthcare Corp has 507 other 510(k) clearances on record.