510(k) K241946
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- by
Bard Peripheral Vascular, Inc.
— Product Code PNG
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2024
- Date Received
- July 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.