# K031852: Sapphire Detachable Fiber Coils

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 20, 2003 after 65 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; 1 cites 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) Fibered GDC VortX Shape: named in the summary without a submission number
- (no number) Guglielmi Detachable Coil: named in the summary without a submission number
- (no number) Target GDC fibered coils: 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
Sapphire Detachable Coils (Non-Fiber) 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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use. Sapphire Detachable Fibered Coil The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K031852
Methodology: https://510kreport.com/methodology