# K060747: FX Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Apr 24, 2007 after 400 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- 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: 5 generations back to K901337 (1990). 11 ancestors in all.
23 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041649: Sapphire NXT Detachable Coil System, Micro Therapeutics, Inc. (2004) Summary page 1.
- K050543: Nexus Detachable Coil System, Micro Therapeutics, Inc. (2005) Summary page 1.
- K051425: Nexus Detachable Coil System, Helix Super Soft CSR, Micro Therapeutics, Inc. (2005) Summary page 1.
- K051560: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR, Micro Therapeutics, Inc. (2005) Summary page 1.

## Most influential descendants
- K081465: Axium Detachable Coil System (2008), 22 descendants of its own
- 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

## 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.
- Nov 12, 2008 · Not classified · Z-0841-2012: ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date sh

## Indications for use
The FX Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The FX Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.

Source page: https://510kreport.com/device/K060747
Methodology: https://510kreport.com/methodology