# K973129: Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits

- Pathway: 510(k) (Traditional)
- Applicant: Denver Biomaterials, Inc.
- Decided: Mar 17, 1998 after 208 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
Longest line of descent: 1 generation back to K894756 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894756: Denver Peritoneo-Venus Shunt, Codman & Shurtleff, Inc. (1989) Summary page 1.
- K913728: Denver (R) Peritoneo-Subclavian Shunt, Denver Biomedicals, Inc. (1994) Summary page 1.
- (no number) Smith & Nephew Ventilation Tubes: named in the summary without a submission number

## Indications for use
Drainage of persistent ascites from the abdominal cavity into the venous system, for use in 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 which is non-responsive to standard medical management *primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure *persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

Source page: https://510kreport.com/device/K973129
Methodology: https://510kreport.com/methodology