# K093968: Osv II Low Flow Low Pro Valve

- Pathway: 510(k) (Special)
- Applicant: Integra LifeSciences Corporation
- Decided: Jan 22, 2010 after 30 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: 3 generations back to K913636 (1991). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042192: Low Flow Osv II Hydrocephalus Valve, Integra Neurosciences Implants S.A. (2004) Summary page 2.
- K033698: Contour-Flex Valve and Shunt System, Integra Neurosciences Implants S.A. (2003) Summary page 2.

## Most influential descendants
- K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models (2015), 0 descendants of its own

## Indications for use
The OSV II Low Flow Low Pro Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Source page: https://510kreport.com/device/K093968
Methodology: https://510kreport.com/methodology