About This 510(k) Submission
K213992 is an FDA 510(k) clearance for the CombiSet Hemodialysis Blood Tubing Set, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 31, 2023, 526 days after receiving the submission on December 21, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.