HydroCoil Embolic System (HydroSoft) and MicroPlex Coil System (HyperSoft)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091641 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 HydroCoil Embolic System (HydroSoft) and MicroPlex Coil System (HyperSoft) are implantable neurovascular embolization coils designed to occlude blood vessels in the brain. These coils consist of platinum wire augmented with a hydrophilic polymer that expands upon contact with blood to promote vessel occlusion. The HydroSoft and HyperSoft variants are part of systems that include a delivery pusher and detachment controller for controlled deployment.
The devices are supplied with a V-Trak delivery pusher and are used in conjunction with a V-Grip detachment controller, which is provided separately. They are intended for single use in neurovascular procedures and must be stored in a dry, sterile environment. The systems are regulated under product code HCG and are classified as Class II devices for neurovascular embolization.
Frequently asked questions
What is the HydroCoil Embolic System used for?
The system is designed for neurovascular embolization, meaning it is used to occlude abnormal or target blood vessels in the brain during endovascular procedures. The platinum wire core provides structural support while the hydrophilic polymer expands on contact with blood to promote rapid and durable vessel closure.
How is the device supplied and what accessories are required for deployment?
Each coil set is provided with a V‑Trak delivery pusher, which advances the coil through the catheter. Deployment is controlled with a V‑Grip detachment controller, which is sold separately. This combination allows the clinician to place and release the coil precisely within the target vessel.
Is the HydroCoil system intended for multiple procedures or single use?
The coils are classified as single‑use devices. After a procedure, the coil and its delivery components must be discarded to maintain sterility and ensure consistent performance in subsequent cases.
What storage conditions are required for the coils?
The coils must be stored in a dry, sterile environment until use. This protects the hydrophilic polymer coating from premature hydration and preserves the integrity of the platinum wire, ensuring the device functions as intended when deployed.
Under which regulatory classification is the HydroCoil system filed?
The HydroCoil Embolic System is classified as a Class II medical device under product code HCG for neurovascular embolization. It received FDA 510(k) clearance (special) based on substantial equivalence to a previously cleared device.
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: HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX… - FDA.report, PDF HydroCoil Embolic System (HES) with the HydroSoft , HydroFill ..., PDF ko? I (0-I - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091641 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K091641 24 fields · synced Sep 25, 2026