About This 510(k) Submission
K213602 is an FDA 510(k) clearance for the Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on January 14, 2022, 60 days after receiving the submission on November 15, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.