# K090357: Hydroframe (Hes)

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Apr 10, 2009 after 57 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K951256 (1995). 45 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082461: Bare Platinum Framing Coil, Model (S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B, MicroVention, Inc. (2008) Summary page 1.
- K080666: Hydrosoft and Hydrosoft Plus Embolization Coil Systems, MicroVention, Inc. (2008) Summary page 1.

## Most influential descendants
- K100454: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V (2010), 9 descendants of its own
- K103758: Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10 (2011), 7 descendants of its own
- K111451: Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX (2011), 4 descendants of its own
- K123384: Azur CX Detachable 18 (2012), 3 descendants of its own
- K132952: Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) (2013), 2 descendants of its own

## 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-1402-2020: The devices may be missing the implant coil.

## Indications for use
The HydroFrame HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. 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 embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K090357
Methodology: https://510kreport.com/methodology