510(k) K120674

MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER by Covidien — Product Code MPB

K120674 is an FDA 510(k) premarket notification submitted by Covidien for the device "MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on April 4, 2012. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Covidien has at least 10 other 510(k) clearances on record.