# K162704: Axium Prime Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jan 3, 2017 after 97 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: 14 generations back to K951256 (1995). 62 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151447: Axium Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2015) Summary page 4.
- K133310: Axium Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2014) Summary page 4.
- K081465: Axium Detachable Coil System, Micro Therapeutics, Inc. (2008) Summary page 4.
- K060747: FX Detachable Coil System, Micro Therapeutics, Inc. (2007) Summary page 4.

## Most influential descendants
- K203432: Axium Detachable Coil; Axium Prime Detachable Coil (2021), 1 descendant of its own
- K233420: Axium Detachable Coil; Axium Prime Detachable Coil (2023), 0 descendants of its own
- K180653: Spartan eCoil System (2018), 0 descendants of its own
- K173711: Wallaby Avenir Coil System (2018), 0 descendants of its own

## Indications for use
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K162704
Methodology: https://510kreport.com/methodology