# K050700: Matrix Stretch Resistant (SR) Coils

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 15, 2005 after 28 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951256 (1995). 29 ancestors in all.
59 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031168: Matrix Stretch Resistant Detachable Coil, Boston Scientific, Target (2003) Summary page 1.
- K012985: Matrix Detachable Coils, Boston Scientific, Target (2002) Summary page 2.
- K042539: GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree Coil, Boston Scientific Corp (2004) Summary page 2.

## Most influential descendants
- K093142: Target Detachable Coils and Inzone Detachment System (2010), 58 descendants of its own
- K103008: Inzone Detachment System (2010), 21 descendants of its own
- K102672: Target Detachable Coil (2010), 16 descendants of its own
- K123338: Barricade Embolization Coil System (2013), 15 descendants of its own
- K112385: Traget Detachable Coil (2011), 15 descendants of its own

## Recalls of this device
- Feb 7, 2007 · Not classified · Z-0668-2007: The product may be missing the temperature indicator label on the inner pouch.

## Indications for use
Matrix 2 Detachable Coils are intended for embolizing certain 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 embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Matrix2 Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K050700
Methodology: https://510kreport.com/methodology