# K071939: Hydrocoil Embolic Systems (Hes)

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Jan 11, 2008 after 182 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K951256 (1995). 48 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983483: Vascular Occlusion System, Cordis Neurovascular, Inc. (1999) Summary page 2.
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes), MicroVention, Inc. (2005) Summary page 2.
- K032590: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes), MicroVention, Inc. (2003) Summary page 2.

## Most influential descendants
- K093002: Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610 (2009), 12 descendants of its own
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K133282: Reverse Medical Micro Vascular Plug (MVP) System (2013), 6 descendants of its own
- K141313: Reverse Medical Micro Vascular Plug System (2014), 5 descendants of its own
- K091882: Azur Peripheral Hydrocoil Endovascular Embolization System (2009), 5 descendants of its own

## Indications for use
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.

Source page: https://510kreport.com/device/K071939
Methodology: https://510kreport.com/methodology