Clearance Summary
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- received FDA 510(k) clearance under submission number K241946, sponsored by Bard Peripheral Vascular, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2024-12-06.
- Submission: K241946
- Applicant / Sponsor: Bard Peripheral Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 2024-12-06
Classification & Regulation
This clearance is catalogued under FDA product code PNG and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.