MOF
- 产品代码
- MOF
- 器械名称
- Guide, Wire, Catheter, Neurovasculature
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 870.1330
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 17 件
- 其中 Summary 已存档
- 17 份,可直接下载
- FDA 历史累计 510(k)
- 44 件(全部年份;本站只收录近三年的明细)
该代码近三年的 510(k)(17 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260751 | 2026-08-27 | Piraeus Medical, Inc. | 35 Helix Guidewire | |
| K262424 | 2026-08-14 | Arbor Endovascular, LLC | Willow 12 Guidewire | |
| K260223 | 2026-08-06 | Scientia Vascular, Inc. | Aristotle Mini Guidewire | |
| K254006 | 2026-07-17 | Rapid Medical Ltd. | Drivewire 35 Guidewire | |
| K253579 | 2026-04-29 | Scientia Vascular, Inc. | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris | |
| K252317 | 2026-04-16 | Suzhou Zenith Vascular SciTech Limited | Zenith Micro Guidewire | |
| K260537 | 2026-03-19 | Arbor Endovascular, LLC | Willow 24 Guidewire | |
| K252122 | 2026-03-16 | Shanghai Achieva Medical Suzhou Co., L | DCwire Micro-guidewire | |
| K260130 | 2026-02-13 | Arbor Endovascular, LLC | Willow 18 Guidewire | |
| K252011 | 2026-02-02 | Asahi Intecc Co., Ltd. | CHIKAI Nexus petit | |
| K253168 | 2025-11-26 | Arbor Endovascular, LLC | 0.014 Willow Guidewire | |
| K244061 | 2025-08-26 | Imperative Care, Inc. | X-Wire Guidewire | |
| K243756 | 2025-07-17 | Arbor Endovascular, LLC | 0.014 Willow Guidewire | |
| K243383 | 2025-04-21 | Asahi Intecc Co., Ltd. | CHIKAI Nexus 014 | |
| K243938 | 2025-04-01 | Scientia Vascular, Inc. | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aris | |
| K240871 | 2024-11-18 | Enlight Medical Technologies (Shenzhen | Synxess Neurovascular Guidewire | |
| K233791 | 2024-07-11 | Rapid-Medical , Ltd. | Drivewire 24 Guidewire |
FDA 官方分类页: MOF
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。