About This 510(k) Submission
K241946 is an FDA 510(k) clearance for the PeritX? 1L Drainage Kit (90-1010); PeritX? 2L Drainage Kit (90-2010); PeritX? Peritoneal Catheter Kit (50-9000C); PeritX? Peritoneal Catheter and Starter Kit (50-9900C); PeritX? Peritoneal Catheter Mini Kit (50-9050A); PleurX? Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX? Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX? Supplemental Insertion Kit (50-7262); Procedure Pack (50-, a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II — Special Controls, product code PNG), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on December 6, 2024, 156 days after receiving the submission on July 3, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.