# K050543: Nexus Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Apr 27, 2005 after 56 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: 3 generations back to K901337 (1990). 8 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 36 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.
- K012985: Matrix Detachable Coils, Boston Scientific, Target (2002) Summary page 1.

## Most influential descendants
- K051560: Nexus Detachable Coil, Multi-Diameter CSR and Helix Super Soft CSR (2005), 24 descendants of its own
- K051425: Nexus Detachable Coil System, Helix Super Soft CSR (2005), 24 descendants of its own
- K060747: FX Detachable Coil System (2007), 23 descendants of its own
- 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

## Indications for use
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus 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/K050543
Methodology: https://510kreport.com/methodology