# K161367: HydroCoil Embolic System (HES)

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Aug 31, 2016 after 106 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K951256 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090357: Hydroframe (Hes), MicroVention, Inc. (2009) Summary page 4.
- K100454: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V, MicroVention, Inc. (2010) Summary page 4.
- K103758: Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10, MicroVention, Inc. (2011) Summary page 4.

## 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-1405-2020: 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-1392-2020: The devices may be missing the implant coil.

## Indications for use
The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The 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/K161367
Methodology: https://510kreport.com/methodology