# K030392: Sapphire Detachable Coil System

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Jul 21, 2003 after 166 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
No predicates in its family tree.
30 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Target Therapeutics’ Detachable Platinum Coil (Guglielmi Detachable Coil, GDC): named in the summary without a submission number

## Most influential descendants
- K033372: Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models (2004), 29 descendants of its own
- 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

## Indications for use
The Sapphire™ 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 Sapphire™ 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/K030392
Methodology: https://510kreport.com/methodology