OAZ

One-Way Air-Leak Valve

产品代码

OAZ

器械名称

One-Way Air-Leak Valve

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

FDA 分类定义

To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.

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）。