510(k) K844108

RENAL SYSTEMS PERITONEAL ACCESS SYSTEM by Renal Systems, Inc. — Product Code FKX

K844108 is an FDA 510(k) premarket notification submitted by Renal Systems, Inc. for the device "RENAL SYSTEMS PERITONEAL ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 1985. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Renal Systems, Inc. has at least 10 other 510(k) clearances on record.