About This 510(k) Submission
K232803 is an FDA 510(k) clearance for the NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on March 14, 2024, 184 days after receiving the submission on September 12, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.