510(k) K831176

FILTRYZER HOLLOW FIBER ARTIF. KIDNEY by Erika, Inc. — Product Code KOC

K831176 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "FILTRYZER HOLLOW FIBER ARTIF. KIDNEY". The FDA issued a decision of Substantially Equivalent on June 22, 1984. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Erika, Inc. has at least 10 other 510(k) clearances on record.