NTE

Temporary Carotid Catheter For Embolic Capture

产品代码

NTE

器械名称

Temporary Carotid Catheter For Embolic Capture

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.1250

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

36 件

FDA 分类定义

This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i

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）。