# K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jan 6, 2015 after 291 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: 4 generations back to K913636 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 4.
- K081773: OSV II, Integra Neurosciences Implants S.A. (2008) Summary page 4.
- K093968: Osv II Low Flow Low Pro Valve, Integra LifeSciences Corporation (2010) Summary page 4.
- K092395: Osv II Lumbar Valve System and Osv II Low Flow Lumbar Valve System, Integra Lifesciences Corp. (2009) Summary page 4.

## Indications for use
Models for ventricular application: The Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with hydocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Models for lumbar application: The Lumbar Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

Source page: https://510kreport.com/device/K140722
Methodology: https://510kreport.com/methodology