QZU
- 产品代码
- QZU
- 器械名称
- Temporary Embolization Assist Device, Peripheral
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 870.3325
- FDA 专业组
- Cardiovascular
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
该代码近三年的 510(k)（1 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| DEN230064 | 2024-02-21 | Rapid Medical Ltd. | BraidE Embolization Assist Device | — |
FDA 官方分类页： QZU
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。