QFC

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

产品代码

QFC

器械名称

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.4783

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)

3 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。