# K040694: Modification to Sapphire Detachable Coil System (Tetris 3-D)

- Pathway: 510(k) (Special)
- Applicant: Micro Therapeutics, Inc.
- Decided: Mar 25, 2004 after 8 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.
29 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K913418: Senographe DMR/SMR/DM, General Electric Co. (1992). Our reading of the summary gave K913418, FDA’s number for Senographe DMR/SMR/DM (General Electric Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sapphire Detachable Coil System”. Kept off the family tree.

## 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 SapphireTM 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 Tm 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/K040694
Methodology: https://510kreport.com/methodology