510(k) K890315

CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G by Baxter Healthcare Corp — Product Code KDI

K890315 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G". The FDA issued a decision of Substantially Equivalent on Feb 8, 1989. 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.