# K153594: MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Jan 22, 2016 after 37 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K951256 (1995). 58 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132952: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes), MicroVention, Inc. (2013) Summary page 4.

## Most influential descendants
- K161452: MicroPlex Coil System (MCS) - HyperSoft 3D (2016), 0 descendants of its own

## Recalls of this device
- Nov 22, 2019 · Class II · Z-1403-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1404-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1399-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1407-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1405-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1394-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1400-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1401-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1402-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1406-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1393-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1392-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1396-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1397-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1395-2020: The devices may be missing the implant coil.
- Nov 22, 2019 · Class II · Z-1398-2020: The devices may be missing the implant coil.

## Indications for use
The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K153594
Methodology: https://510kreport.com/methodology