NIV
- 产品代码
- NIV
- 器械名称
- Coronary Covered Stent
- 管理类别
- 第 F 类(HDE)
- FDA 专业组
- Unknown
- 上市路径
- HDE - Humanitarian Device Exemption
- 标记
- 属植入器械
- 标记
- 属生命支持/维持器械
FDA 分类定义
Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
FDA 官方分类页: NIV
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。