# 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-

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Dec 6, 2024 after 156 days
- Product code: PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K932323 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201155: PleurX Peritoneal Catheter System, Care Fusion (2020) Summary page 6.

## Indications for use
The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage. The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only. The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method. For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only. For Peritoneal Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX™ Low Profile Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX™ Low Profile Catheter is indicated for adults only. The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method. The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission. For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids. For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance. The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage. The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction). The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space. The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site. The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

Source page: https://510kreport.com/device/K241946
Methodology: https://510kreport.com/methodology