Identifiers
- 510(k) Number
- K012145 FDA 510(k)
- FDA Product Code
- HCG 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 MicroPlex Coil System is a neurovascular embolization device designed for the endovascular treatment of intracranial aneurysms and other neurovascular abnormalities. It consists of implantable coils delivered via a V-Trak delivery pusher, forming a framework within the aneurysm sac to promote thrombosis and occlusion.
The system is supplied as a sterile, single-use device, intended for use in interventional radiology or neurointerventional procedures. It is classified as a Class II medical device under FDA regulations (882.5950) and requires FDA 510(k) clearance. Coils are available in multiple reference codes for various aneurysm sizes, and the V-Grip detachment controller is provided separately for coil deployment.
Frequently asked questions
What types of neurovascular abnormalities is the MicroPlex Coil System specifically designed to treat?
The MicroPlex Coil System is designed for the endovascular treatment of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations (AVMs) or vascular lesions, where occlusion of the blood vessel is required to promote thrombosis and prevent blood flow.
Is the MicroPlex Coil System reusable, or is it intended for single-use only?
The MicroPlex Coil System is explicitly supplied as a sterile, single-use device, meaning each coil and delivery system is intended for one procedure only to ensure patient safety and sterility.
How is the MicroPlex Coil System deployed during a procedure, and what components are included?
The system is deployed using a V-Trak delivery pusher to position the coils within the aneurysm sac. The V-Grip detachment controller is provided separately to control the release of the coils once they are properly placed. The coils themselves come in multiple reference codes to accommodate various aneurysm sizes.
What regulatory pathway was followed for FDA clearance of the MicroPlex Coil System?
The MicroPlex Coil System received FDA 510(k) clearance through a traditional review pathway, with a decision described as substantially equivalent to a predicate device. The advisory committee involved was the Neurology (NE) Panel, and the system is classified as a Class II medical device under FDA regulations (882.5950).
Are there different sizes or models of coils available, and how do I determine the right one for a patient?
Yes, the system includes multiple coil reference codes tailored to different aneurysm sizes. The selection should be based on the specific dimensions of the aneurysm sac, as documented in imaging studies, to ensure proper occlusion and thrombosis. Consult the manufacturer’s sizing guidelines or product catalog for compatibility.
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: PDF MicroPlexTM Coil System (MCS) - assets.ctfassets.net, PDF MicroVention Coil Portfolio, PDF Section 2 Summary of Safety and Effectiveness
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012145 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K012145 24 fields · synced Sep 19, 2026