510(k) K822796

NEGATIVE PRESSURE ARTERIAL BLOOD LINE by Erika, Inc. — Product Code KOC

K822796 is an FDA 510(k) premarket notification submitted by Erika, Inc. for the device "NEGATIVE PRESSURE ARTERIAL BLOOD LINE". The FDA issued a decision of Substantially Equivalent on October 18, 1982. 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.