# K160437: PleurX Peritoneal Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Nov 3, 2016 after 260 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: 6 generations back to K932323 (1993). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer, Care Fusion (2012) Summary page 5.
- K110396: Aspira Peritoneal Drainage System, C.R. Bard, Inc. (2011) Summary page 5.

## Most influential descendants
- K201155: PleurX Peritoneal Catheter System (2020), 1 descendant of its own
- 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- (2024), 0 descendants of its own

## Indications for use
The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites. The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The PleurX Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the PleurX Valve. The PleurX LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.

Source page: https://510kreport.com/device/K160437
Methodology: https://510kreport.com/methodology