MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153594 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 (MCS) and Hydrocoil Embolic System (HES) are implantable devices designed for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, including arteriovenous malformations and arteriovenous fistulae. They are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow.
The system consists of an implantable coil attached to a delivery system known as the V-Trak delivery pusher, which is powered by a V-Grip detachment mechanism. It is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K153594) with product code HCG and device class II.
Frequently asked questions
What is the MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES) used for?
The MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES) are implantable devices designed for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, including arteriovenous malformations and arteriovenous fistulae. They are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow.
How is the MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES) supplied and is it reusable?
The system is supplied as a sterile, single-use device. It consists of an implantable coil attached to a delivery system known as the V-Trak delivery pusher, which is powered by a V-Grip detachment mechanism. Because it is sterile and single-use, it is not intended for reuse, reprocessing, or resterilization to maintain patient safety and device integrity.
What regulatory pathway was used for the MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES)?
The MicroPlex Coil System (MCS) and Hydrocoil Embolic System (HES) are regulated under FDA 510(k) clearance (K153594) with product code HCG and device class II. This indicates the device was found substantially equivalent to a legally marketed predicate device through the 510(k) premarket notification process.
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 Summary of Safety and Clinical Performance for MicroPlexTM Coil System ..., Microplex Coil System (Mcs), Hydrocoil Embolic System (Hes) (K032590 ..., PDF MicroPlexTM Coil System (MCS)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153594 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K153594 24 fields · synced Sep 22, 2026