HCG · Device, Neurovascular Embolization
Neurology · 21 CFR 882.5950 · Class 2
Overview
| Product Code | HCG |
|---|---|
| Device Name | Device, Neurovascular Embolization |
| Regulation | 21 CFR 882.5950 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.
Classification Rationale
Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
Recent Cleared Devices (20 of 184)
Showing 20 most recent of 184 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | Jan 27, 2026 | SESE |
| K252694 | Target Detachable Coil | Stryker Neurovascular | Dec 11, 2025 | SESE |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | Oct 17, 2025 | SESE |
| K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | Sep 26, 2025 | SESE |
| K242154 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | Sep 30, 2024 | SESE |
| K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | Sep 27, 2024 | SESE |
| K242243 | Target Detachable Coils | Stryker Neurovscular | Aug 29, 2024 | SESE |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | Jan 10, 2024 | SESE |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | Nov 7, 2023 | SESE |
| K230284 | Penumbra LP Coil System | Penumbra, Inc. | Oct 25, 2023 | SESE |
| K222533 | Target Tetra Detachable Coils | Stryker Neurovascular | Dec 14, 2022 | SESE |
| K223386 | Optima Coil System | Balt USA, LLC | Dec 6, 2022 | SESE |
| K220040 | CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems | Medos International SARL | Jul 14, 2022 | SESE |
| K212455 | InZone Detachment System | Stryker Neurovascular | Nov 16, 2021 | SESE |
| K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | Sep 1, 2021 | SESE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Jul 7, 2021 | SESE |
| K211344 | MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems | Medos International SARL | May 28, 2021 | SESE |
| K210638 | i-ED COIL System | Kaneka Medical America, LLC | Mar 26, 2021 | SESE |
| K192068 | i-ED COIL | Kaneka Pharma America, LLC | Apr 25, 2020 | SESE |
| K200030 | Optima Coil System | Balt USA, LLC | Feb 1, 2020 | SESE |
Top Applicants
- MicroVention, Inc. — 32 clearances
- Cordis Neurovascular, Inc. — 12 clearances
- Boston Scientific Corp — 11 clearances
- Boston Scientific, Target — 11 clearances
- Micro Therapeutics, Inc. — 11 clearances
