Numen Helia Coil Embolization System; NumenFR Detachment System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K260351 FDA 510(k)
- FDA Product Code
- HCG FDA 510(k)
- Models / Variants
- Numen™ Helia Coil Embolization System FDA 510(k)NumenFR™ Detachment System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5950 FDA 510(k)
- Regulation Number
- 882.5950 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Numen Helia Coil Embolization System is a neurovascular embolization device designed for endovascular treatment of intracranial aneurysms and other neurovascular abnormalities, including arteriovenous malformations and fistulae. It employs coil-based embolization to occlude abnormal blood vessels, reducing the risk of rupture or hemorrhage in high-risk vascular conditions.
This system is supplied as a sterile, single-patient-use device, intended for use in interventional radiology or neurointerventional settings. The NumenFR Detachment System is a handheld device paired with the embolization coils, enabling precise detachment of coils within the vascular target. The system is classified under FDA 510(k) clearance (K260351) and adheres to regulatory standards for neurovascular embolization devices, including MRI safety considerations for coil materials. Multiple coil sizes and configurations are available for tailored clinical applications.
Frequently asked questions
What types of neurovascular conditions is the Numen Helia Coil Embolization System specifically designed to treat?
The Numen Helia Coil Embolization System is designed for endovascular treatment of intracranial aneurysms, as well as other neurovascular abnormalities such as arteriovenous malformations (AVMs) and fistulae. It uses coil-based embolization to occlude abnormal blood vessels, helping to reduce the risk of rupture or hemorrhage in these high-risk conditions.
Is the Numen Helia Coil Embolization System intended for single-use or repeated use in a single patient?
The Numen Helia Coil Embolization System is supplied as a sterile, single-patient-use device. This means each coil system is intended for use in one procedure and should not be reused, ensuring patient safety and sterility.
How is the detachment of coils within the vascular target achieved, and what role does the NumenFR Detachment System play?
The NumenFR Detachment System is a handheld device paired with the embolization coils, enabling precise detachment of coils within the targeted vascular area. This system allows clinicians to release the coils at the exact location needed for effective embolization during interventional procedures.
Are there multiple sizes or configurations of coils available for different clinical applications?
Yes, the Numen Helia Coil Embolization System offers multiple coil sizes and configurations to accommodate tailored clinical needs. This flexibility ensures that the device can be selected based on the specific anatomy and requirements of the patient’s neurovascular condition.
What considerations should be taken into account regarding MRI safety when using the Numen Helia Coil Embolization System?
The Numen Helia Coil Embolization System adheres to MRI safety standards for coil materials, meaning it is designed to be compatible with MRI imaging procedures. This ensures that patients can undergo follow-up imaging without concerns related to the device’s interaction with MRI equipment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NUMEN™ Coil Embolization System — Microport Neuroscientific, Numen™ Coil Embolization System; NumenFR™ Detachment System, Numen Coil Embolization System; NumenFR Detachment System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K260351 | Class II | Active |
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Manufacturer
- Manufacturer
- MicroPort NeuroTech (Shanghai) Co., Ltd.
Sources (1)
- FDA 510(k) K260351 24 fields · synced Sep 19, 2026