# K170405: BD Curve Ascites Shunt

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: Nov 2, 2017 after 265 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: 6 generations back to K932323 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011862: Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt, Denver Biomedical, Inc. (2001) Summary page 4.
- K132498: Valved Tearaway Introducer Generation II, Medcomp (Medical Components, Inc.) (2013) Summary page 4.
- K122422: Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable Introducer, Care Fusion (2012) Summary page 4.

## Indications for use
Peritoneovenous shunting is indicated for patients with malignant or non-malignant intractable ascites (including patients with chylous ascites, hepatorenal syndrome, and idiopathic ascites), not responding to standard medical management, and not considered candidates for portal-venous shunting The 17Fr valved peel-away introducer is intended for use in the percutaneous insertion of catheters in the peritoneal space. The 15.5Fr Pigtail Revision Catheter is indicated for revising the peritoneal catheter of an BD Curve Ascites Shunt.

Source page: https://510kreport.com/device/K170405
Methodology: https://510kreport.com/methodology