# K964386: Radionics Contour Flex Plus Valve

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Jan 31, 1997 after 88 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radionics Contour Flex Valve: named in the summary without a submission number
- (no number) PS Medical Delta CSF Flow Control Valve: named in the summary without a submission number

## Most influential descendants
- K042558: Equi-Flow Valve and Shunt System (2004), 0 descendants of its own

## Indications for use
The Contour Flex Plus Valve 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. It also prevents over-drainage of CSF due to siphoning.

Source page: https://510kreport.com/device/K964386
Methodology: https://510kreport.com/methodology