QWA
- 产品代码
- QWA
- 器械名称
- Cardiovascular Delivery Catheter System Positioning And Stabilization Device
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 870.3955
- FDA 专业组
- Cardiovascular
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
FDA 分类定义
A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.
FDA 官方分类页： QWA
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。