510(k) K882680

ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA by Baxter Healthcare Corp — Product Code FJI

K882680 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA". The FDA issued a decision of Substantially Equivalent on Jul 22, 1988. 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.