# K020434: Microplex Coil System (MCS)

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jul 29, 2002 after 171 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
Longest line of descent: 6 generations back to K951256 (1995). 29 ancestors in all.
70 later devices descend from it; 2 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993417: GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil (GDC) (3D Shape GDC), Boston Scientific, Target (2000) Summary page 2.
- K012145: Microplex Coil System, MicroVention, Inc. (2001) Summary page 2.
- K012985: Matrix Detachable Coils, Boston Scientific, Target (2002)

## Most influential descendants
- 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
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own

## Indications for use
The MicroPlex Coil System (MCS) is 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 very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K020434
Methodology: https://510kreport.com/methodology