# K091641: Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Jun 30, 2009 after 26 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K951256 (1995). 43 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070656: Hydrocoil Embolic System (Hes), MicroVention, Inc. (2007) Summary page 1.
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes), MicroVention, Inc. (2005) Summary page 2.

## Most influential descendants
- K112226: Hydrocoil Embolic System (Hes) (2011), 21 descendants of its own
- K113457: Hydrocoil Embolic System (Hes) (2011), 20 descendants of its own
- K120908: Hydrocoil Embolic System (Hes) (2012), 19 descendants of its own
- K123338: Barricade Embolization Coil System (2013), 15 descendants of its own
- K131475: Barricade Embolization Coil System (2013), 14 descendants of its own

## Recalls of this device
- 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-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-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.

## Indications for use
The Hydro Coil Embolic System and MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES/MCS is 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/K091641
Methodology: https://510kreport.com/methodology