# K042558: Equi-Flow Valve and Shunt System

- Pathway: 510(k) (Traditional)
- Applicant: Integra Neurosciences Implants S.A.
- Decided: Oct 6, 2004 after 15 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954285 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033698: Contour-Flex Valve and Shunt System, Integra Neurosciences Implants S.A. (2003) Summary page 1.
- K964386: Radionics Contour Flex Plus Valve, Radionics, Inc. (1997) Summary page 1.
- K971511: Radionics Contour Flex Valve, Radionics Contour Flex Plus Valve, Radionics, Inc. (1997) Summary page 1.

## Indications for use
The Equi-FlowTM Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. The Equi-FlowTM Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.

Source page: https://510kreport.com/device/K042558
Methodology: https://510kreport.com/methodology