About This 510(k) Submission
K192302 is an FDA 510(k) clearance for the Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on January 17, 2020, 147 days after receiving the submission on August 23, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.