# K233420: Axium Detachable Coil; Axium Prime Detachable Coil

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
- Decided: Nov 7, 2023 after 28 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: 16 generations back to K951256 (1995). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203432: Axium Detachable Coil; Axium Prime Detachable Coil, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (2021) Summary page 4.

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

Source page: https://510kreport.com/device/K233420
Methodology: https://510kreport.com/methodology