About This 510(k) Submission
K172238 is an FDA 510(k) clearance for the CAREline Airless Hemodialysis Blood Tubing Sets, a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on December 14, 2017, 141 days after receiving the submission on July 26, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.