# K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jun 28, 2005 after 74 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: 10 generations back to K951256 (1995). 41 ancestors in all.
65 later devices descend from it; 9 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032590: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes), MicroVention, Inc. (2003) Summary page 2.
- K033836: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2003) Summary page 2.
- K041551: Modification to: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2004) Summary page 2.
- K031578: Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR, Micrus Corp. (2003) Summary page 2.

## Most influential descendants
- K070656: Hydrocoil Embolic System (Hes) (2007), 36 descendants of its own
- K082461: Bare Platinum Framing Coil, Model (S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B (2008), 35 descendants of its own
- K080666: Hydrosoft and Hydrosoft Plus Embolization Coil Systems (2008), 34 descendants of its own
- K090891: Microplex Coil System-Cosmos (2009), 27 descendants of its own
- K091641: Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft) (2009), 23 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 HydroCoir 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/K050954
Methodology: https://510kreport.com/methodology