# K033836: Hydrocoil Embolic System (Hes)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Dec 30, 2003 after 20 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: 8 generations back to K951256 (1995). 37 ancestors in all.
67 later devices descend from it; 3 cite it directly.
0 of 105 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.
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1, Boston Scientific, Target (2000) Summary page 2.
- K993418: Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil, Boston Scientific, Target (2000) Summary page 2.

## Most influential descendants
- K041551: Modification to: Hydrocoil Embolic System (Hes) (2004), 66 descendants of its own
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), 65 descendants of its own
- 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

## Indications for use
The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES 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/K033836
Methodology: https://510kreport.com/methodology