HCG
- 产品代码
- HCG
- 器械名称
- Device, Neurovascular Embolization
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.5950
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 187 件
该代码近三年的 510(k)（13 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K262419 | 2026-08-14 | Cerenovus, Inc. | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MI | |
| K261772 | 2026-06-24 | Stryker Neurovscular | Target Xtra Detachable Coil | |
| K260351 | 2026-05-20 | MicroPort NeuroTech (Shanghai) Co., Lt | Numen Helia Coil Embolization System; NumenFR Deta | FDA |
| K254221 | 2026-01-27 | Balt USA, LLC | Optima Coil System (OptiOne Coil System) | |
| K252694 | 2025-12-11 | Stryker Neurovascular | Target Detachable Coil | |
| K251832 | 2025-10-17 | Stryker Neurovascular | InZone IST Detachment System; IZDS Connecting Cable | |
| K252700 | 2025-09-26 | Balt USA, LLC | Optima Coil System (Optima Packing Coil System) | |
| K242154 | 2024-09-30 | MicroPort NeuroTech (Shanghai) Co., Lt | Numen Coil Embolization System; NumenFR Detachment | |
| K242582 | 2024-09-27 | Balt USA, LLC | Optima Coil System (OptiBlock Line Extension) | |
| K242243 | 2024-08-29 | Stryker Neurovscular | Target Detachable Coils | |
| K232955 | 2024-01-10 | MicroPort NeuroTech (Shanghai) Co., Lt | Numen Coil Embolization System; NumenFR Detachment S | FDA |
| K233420 | 2023-11-07 | Micro Therapeutics Lnc. D/B/A Ev3 Neur | Axium Detachable Coil; Axium Prime Detachable Coil | FDA |
| K230284 | 2023-10-25 | Penumbra, Inc. | Penumbra LP Coil System |
FDA 官方分类页： HCG
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。