# K051711: Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomedical, Inc.
- Decided: Nov 15, 2005 after 141 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
No predicates in its family tree.
17 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pleurx Catheter: named in the summary without a submission number

## Most influential descendants
- K113854: Pleurx Peritoneal Catheter System (2012), 8 descendants of its own
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer (2012), 4 descendants of its own
- K152105: Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (2016), 3 descendants of its own
- K093796: Asept Peritoneal Drainage System (2010), 3 descendants of its own
- K160437: PleurX Peritoneal Catheter System (2016), 2 descendants of its own

## Indications for use
The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for: Intermittent drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying diseasc Palliation of symptoms related to recurrent malignant ascites Peritoneal placcment only The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleurx Pleural Catheter Kit.

Source page: https://510kreport.com/device/K051711
Methodology: https://510kreport.com/methodology