# K192068: i-ED COIL

- Pathway: 510(k) (Traditional)
- Applicant: Kaneka Pharma America, LLC
- Decided: Apr 25, 2020 after 268 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: 22 generations back to K951256 (1995). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161429: Target Detachable Coils, Stryker Neurovascular (2016) Summary page 5.
- K160096: InZone Detachment System, Stryker Neurovascular (2016) Summary page 5.
- K162999: V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System, MicroVention, Inc. (2017) Summary page 5.
- K151760: Barricade Embolization Coil System, Blockade Medical (2015) Summary page 5.

## Most influential descendants
- K210638: i-ED COIL System (2021), 0 descendants of its own

## Indications for use
The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System 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/K192068
Methodology: https://510kreport.com/methodology