# K081465: Axium Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 19, 2008 after 84 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K951256 (1995). 59 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060747: FX Detachable Coil System, Micro Therapeutics, Inc. (2007) Summary page 1.
- K073442: Micrus Microcoil Systems, Micrus Endovascular Corporation (2008) Summary page 1.
- K962503: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 1.

## Most influential descendants
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K133310: Axium Detachable Coil System (2014), 6 descendants of its own
- K133282: Reverse Medical Micro Vascular Plug (MVP) System (2013), 6 descendants of its own
- K151447: Axium Detachable Coil System (2015), 5 descendants of its own
- K141313: Reverse Medical Micro Vascular Plug System (2014), 5 descendants of its own

## Recalls of this device
- Mar 1, 2010 · Not classified · Z-0873-2012: ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
- Mar 1, 2010 · Not classified · Z-0874-2012: ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.

## Indications for use
The AXIUMTM DETACHABLE COIL SYSTEM is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The AXIUMTM DETACHABLE COILs are also indicated for arterial and venous embolizations in the peripheral vaseulature.

Source page: https://510kreport.com/device/K081465
Methodology: https://510kreport.com/methodology