QPX
- 产品代码
- QPX
- 器械名称
- Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4683
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
FDA 官方分类页： QPX
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。