NPE

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

产品代码

NPE

器械名称

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

标记

属生命支持/维持器械

FDA 分类定义

This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.

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）。