# K172006: Alivio Ventricular Catheter and Flusher System (Alivio System)

- Pathway: 510(k) (Traditional)
- Applicant: Alcyone Lifesciences, Inc.
- Decided: Nov 9, 2017 after 129 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: 2 generations back to K954285 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033698: Contour-Flex Valve and Shunt System, Integra Neurosciences Implants S.A. (2003) Summary page 4.

## Most influential descendants
- K221918: ReFlow System Mini (2022), 1 descendant of its own
- K223603: Reflow System Mini and ReFlow Mini Flusher (2022), 0 descendants of its own

## Indications for use
The Alivio Ventricular Catheter and Flusher System (Alivio System) is for use in the treatment of patients with hydrocephalus, as components of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated. The Alivio Flusher may be used by a qualified clinician as a tool to facilitate a non-invasive retrograde fluid flush of the Alivio Ventricular Catheter to unblock inlet holes or open its relief membrane to restore or increase CSF flow in a non-flowing shunt. The Alivio Flusher is not intended to change standard care practices for diagnosis, treatment, or follow-up of patients with proximal catheter occlusions.

Source page: https://510kreport.com/device/K172006
Methodology: https://510kreport.com/methodology