# K033372: Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jan 9, 2004 after 79 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: 1 generation back to K901337 (1990). 3 ancestors in all.
29 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031852: Sapphire Detachable Fiber Coils, Micro Therapeutics, Inc. (2003) Summary page 1.
- K030392: Sapphire Detachable Coil System, Micro Therapeutics, Inc. (2003) Summary page 1.
- K901337: Hilal Embolization Microcoil (TM), Cook, Inc. (1990) Summary page 1.

## Most influential descendants
- K041649: Sapphire NXT Detachable Coil System (2004), 28 descendants of its own
- 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

## Indications for use
The Sapphire Detachable Fibered 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 Sapphire Detachable Fibered 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/K033372
Methodology: https://510kreport.com/methodology