510(k) K883644

CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 by Baxter Healthcare Corp — Product Code FJI

K883644 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170". The FDA issued a decision of Substantially Equivalent on Oct 21, 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.