# K012985: Matrix Detachable Coils

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific, Target
- Decided: Jan 31, 2002 after 147 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001083 (2000). 1 ancestor in all.
122 later devices descend from it; 4 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001083: Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables: 451102-4, Boston Scientific, Target (2000) Summary page 1.

## Most influential descendants
- K031168: Matrix Stretch Resistant Detachable Coil (2003), 100 descendants of its own
- K020434: Microplex Coil System (MCS) (2002), 70 descendants of its own
- K032590: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) (2003), 68 descendants of its own
- K033836: Hydrocoil Embolic System (Hes) (2003), 67 descendants of its own
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own

## Recalls of this device
- Oct 19, 2010 · Not classified · Z-0855-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0856-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0863-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0860-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0862-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0854-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0857-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0858-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0859-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
- Oct 19, 2010 · Not classified · Z-0861-2011: The product appears to have premature degradation of the PGLA coating on the Matrix Coil.

## Indications for use
The Matrix™ Detachable Coils have the same indications for use as the predicate GDC coils. Matrix™ Detachable Coils are intended for embolization of those 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) inoperable, and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K012985
Methodology: https://510kreport.com/methodology