ODY

Tunneled Catheter Remover

产品代码

ODY

器械名称

Tunneled Catheter Remover

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.5970

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

2 件

FDA 分类定义

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

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）。