# K980903: Radionics Equi-Flow Valve, Ventricular and Peritoneal Catheter with EZ-Coat

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Apr 19, 1999 after 405 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Plus Valve: named in the summary without a submission number
- (no number) Radionics Mini and Standard Shunt Valve Systems: named in the summary without a submission number

## Indications for use
The Radionics Equi-Flow™ Valve, Ventricular Catheter, and Peritoneal Catheter with EZ-Coat™ are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the peritoneal cavity. The Equi-Flow™ Valve with EZ-Coat™ is indicated for 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/K980903
Methodology: https://510kreport.com/methodology