# K260351: Numen™ Helia Coil Embolization System; NumenFR™ Detachment System

- Pathway: 510(k) (Special)
- Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.
- Decided: May 20, 2026 after 106 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: 17 generations back to K951256 (1995). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242154: Numen™ Coil Embolization System; NumenFR™ Detachment System, MicroPort NeuroTech (Shanghai) Co., Ltd. (2024) Summary page 5.

## Indications for use
Numen Helia Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen Helia Coil Embolization System is indicated for endovascular embolization of: • Intracranial aneurysms • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae • Arterial and venous embolizations in the peripheral vasculature NumenFR Detachment System is intended for use with MicroPort NeuroTech detachable coils in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature

Source page: https://510kreport.com/device/K260351
Methodology: https://510kreport.com/methodology