OMR

Vessel Guard Or Cover

产品代码

OMR

器械名称

Vessel Guard Or Cover

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.3470

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

标记

属植入器械

该代码近三年的 510(k)

10 件

FDA 分类定义

These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.

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）。