510(k) K905228

MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ by Baxter Healthcare Corp — Product Code FJI

K905228 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ". The FDA issued a decision of Substantially Equivalent on Dec 10, 1990. 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.