K241946
- 510(k) number
- K241946
- Device name
- 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-
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- PNG — Peritoneal, Drainage Catheter For Refractory Ascites
- Decision date
- 2024-12-06
- Date received
- 2024-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241946.pdf
Official FDA record: K241946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.