# K203432: Axium Detachable Coil; Axium Prime Detachable Coil

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Jul 7, 2021 after 226 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133310: Axium Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2014) Summary page 4.
- K151447: Axium Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2015) Summary page 4.
- K162704: Axium Prime Detachable Coil System, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2017) Summary page 4.

## Most influential descendants
- K233420: Axium Detachable Coil; Axium Prime Detachable Coil (2023), 0 descendants of its own

## Recalls of this device
- Apr 27, 2022 · Class II · Z-1261-2022: Due to incorrect size and configuration labeling of the detachable coil system.

## Indications for use
AxiumTM Detachable Coil: AxiumTM Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axiumm Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Axiummi Prime Detachable Coil (Model Numbers APB-X-Y-3D/HX-ES/SS): The AxiumTM Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The AxiumTM Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Axiummi Prime Detachable Coil (Model Numbers FC-X-Y-3D): The AxiumTM Prime Detachable Coil is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The AxiumTM Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K203432
Methodology: https://510kreport.com/methodology