KRD
- 产品代码
- KRD
- 器械名称
- Device, Vascular, For Promoting Embolization
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.3300
- FDA 专业组
- Cardiovascular
- 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)
- 132 件
该代码近三年的 510(k)（22 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K252812 | 2026-07-31 | Suzhou Haowei Medical Technology Co., | UniPearls® Embolic Microspheres 摘要 |
| K261488 | 2026-07-24 | Boston Scientific Corporation | OBSIDIO Conformable Embolic 摘要 |
| K261866 | 2026-06-24 | Medtronic, Inc. | Concerto Versa Detachable Coil 摘要 |
| K260635 | 2026-06-12 | Nuvascular, Inc. | HARBOR Occlusion Device 摘要 |
| K260508 | 2026-04-10 | Okami Medical, Inc. | LOBO Vascular Occlusion System 摘要 |
| K253511 | 2026-01-14 | Medtronic, Inc. | Concerto Versa Detachable Coil 摘要 |
| K253677 | 2025-12-15 | Instylla, Inc. | Tembo Embolic System 摘要 |
| K253376 | 2025-10-30 | Boston Scientific Corporation | OBSIDIO Conformable Embolic (M0013972101010) 摘要 |
| K250209 | 2025-09-23 | Canyon Medical, Inc. | Polyvinyl Alcohol Embolic Microspheres 摘要 |
| K250133 | 2025-07-09 | Nuvascular, Inc. | HARBOR Occlusion Device 摘要 |
| K251383 | 2025-05-30 | Balt USA, LLC | Prestige Coil System (Prestige Packing Line Extensio 摘要 |
| K250971 | 2025-05-16 | Biosphere Medical, S.A. | Embosphere Microspheres 摘要 |
| K250276 | 2025-05-15 | Embolization, Inc. | Nitinol Enhanced Device (NED) 摘要 |
| K250079 | 2025-03-14 | Penumbra, Inc. | Ruby XL System 摘要 |
| K242608 | 2025-01-17 | Varian Medical Systems, Inc. | Embozene Color-Advanced Microspheres 摘要 |
| K240873 | 2024-12-16 | Instylla, Inc. | TEMBO Embolic System 摘要 |
| K242794 | 2024-10-16 | Varian Medical Systems, Inc. | ONCOZENE Microspheres 摘要 |
| K242507 | 2024-10-03 | Boston Scientific | OBSIDIO Conformable Embolic 摘要 |
| K232934 | 2024-05-30 | Hangzhou Yangshun Medical Technology C | Sunsphere 摘要 |
| K240261 | 2024-05-02 | Merit Medical Systems, Inc. | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular P 摘要 |
| K234123 | 2024-02-13 | Abk Biomedical, Inc. | Easi-Vue® embolic microspheres System 摘要 |
| K231554 | 2023-11-14 | Suzhou Haowei Medical Technology Co., | UniPearls® Embolic Microspheres 摘要 |
FDA 官方分类页： KRD
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。