# K080666: Hydrosoft and Hydrosoft Plus Embolization Coil Systems

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jul 11, 2008 after 123 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: 12 generations back to K951256 (1995). 43 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 78 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.

## 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

## Indications for use
The HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. The HydroSoft and HydroSoft Plus Embolization Coils Systems also are 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 embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K080666
Methodology: https://510kreport.com/methodology