# K011862: Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt

- Pathway: 510(k) (Special)
- Applicant: Denver Biomedical, Inc.
- Decided: Jul 12, 2001 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K170405: BD Curve Ascites Shunt (2017), 0 descendants of its own

## Indications for use
Peritoneo-venous shunting is indicated for patients with: . chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management. . persistent ascites who are not considered candidates for portal-venous shunting. . persistent ascites that is non-responsive to standard medical management.. . primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure. Peritoneo-venous shunting should also be considered for patients with hepatorenal syndrome, chylous ascites and idiopathic ascites.

Source page: https://510kreport.com/device/K011862
Methodology: https://510kreport.com/methodology