# K033698: Contour-Flex Valve and Shunt System

- Pathway: 510(k) (Special)
- Applicant: Integra Neurosciences Implants S.A.
- Decided: Dec 17, 2003 after 22 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954285 (1996). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954285: Contour Flex Valves (Regular & Small), Radionics, Inc. (1996) Summary page 1.
- (no number) Contour-Flex and Shunt System: named in the summary without a submission number

## Most influential descendants
- K172006: Alivio Ventricular Catheter and Flusher System (Alivio System) (2017), 2 descendants of its own
- K221918: ReFlow System Mini (2022), 1 descendant of its own
- K093968: Osv II Low Flow Low Pro Valve (2010), 1 descendant of its own
- K223603: Reflow System Mini and ReFlow Mini Flusher (2022), 0 descendants of its own
- K140722: Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models (2015), 0 descendants of its own

## Recalls of this device
- Aug 23, 2016 · Class II · Z-2905-2016: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

## Indications for use
The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid fro the ventricles of the brain to an appropriate drainage site such as the atrium of the heart of to the peritoneal cavity.

Source page: https://510kreport.com/device/K033698
Methodology: https://510kreport.com/methodology