# K173711: Wallaby Avenir Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Wallaby Medical, Inc.
- Decided: May 4, 2018 after 151 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K951256 (1995). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162704: Axium Prime Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2017) Summary page 4.

## Indications for use
The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K173711
Methodology: https://510kreport.com/methodology