510(k) K151967

Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter by Merit Medical Systems, Inc. — Product Code MSD

K151967 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter". The FDA issued a decision of Substantially Equivalent (kit) on April 4, 2016. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.