# K962814: Denver Pleural Effusion Shunt with External Pump Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomaterials, Inc.
- Decided: Apr 14, 1997 after 269 days
- Product code: KPM (Shunt, Peritoneal)
- Device class: 2
- Regulation: 21 CFR 876.5955
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Denver® Pleural Effusion Shunt: named in the summary without a submission number
- (no number) Cook, Inc. Pneumothorax Set: named in the summary without a submission number
- (no number) Quinton Tenckhoff Peritoneal Dialysis Catheter: named in the summary without a submission number

## Indications for use
The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is indicated for use in transferring pleural fluid, resulting from chylothorax or intractable pleural effusion, from the pleural cavity to the peritoneal cavity. The device is intended to be used in adult, pediatric, and neonatal patients.

Source page: https://510kreport.com/device/K962814
Methodology: https://510kreport.com/methodology