# K041649: Sapphire NXT Detachable Coil System

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jul 16, 2004 after 29 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: 2 generations back to K901337 (1990). 5 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030392: Sapphire Detachable Coil System, Micro Therapeutics, Inc. (2003) Summary page 1.
- K033372: Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models, Micro Therapeutics, Inc. (2004) Summary page 1.
- K040694: Modification to Sapphire Detachable Coil System (Tetris 3-D), Micro Therapeutics, Inc. (2004) Summary page 1.

## Most influential descendants
- K050543: Nexus Detachable Coil System (2005), 27 descendants of its own
- 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

## Indications for use
The Sapphire TM 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 SapphireTM 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/K041649
Methodology: https://510kreport.com/methodology