510(k) K192302

Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter by Covidien, LLC — Product Code MPB

K192302 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 17, 2020. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Covidien, LLC has at least 10 other 510(k) clearances on record.