# K971753: Denver Pleurx Pleural Catheter Kit, Catalog NO. 50-7000, Denver Pleurx Home Drainage Kit, Catalog NO. 50-7500

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomaterials, Inc.
- Decided: Jun 27, 1997 after 46 days
- Product code: DWM (Apparatus, Suction, Patient Care)
- Device class: 2
- Regulation: 21 CFR 870.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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) Argyle® Silicone Thoracic Catheter: named in the summary without a submission number
- (no number) Denver® Pleural Effusion Shunt with Externalized Pump Chamber: named in the summary without a submission number

## Most influential descendants
- K071095: Aspira Pleural Drainage System (2007), 9 descendants of its own
- K110409: Aspira Pleural Drainage System (2011), 8 descendants of its own
- K112831: Pleurx Pleural Catheter Systems (2012), 6 descendants of its own
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B (2013), 2 descendants of its own
- K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee (2012), 2 descendants of its own

## Indications for use
The Denver® PLEURX Pleural Catheter Kit and Denver® PLEURX Home Drainage Kit are indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant pleural effusion. The devices are indicated for the palliation of dyspnea due to malignant pleural effusion and for providing pleurodesis.

Source page: https://510kreport.com/device/K971753
Methodology: https://510kreport.com/methodology