SCT

Foley Catheters And Accessories With Additional Safety Features

产品代码: SCT
器械名称: Foley Catheters And Accessories With Additional Safety Features
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 876.5130
FDA 专业组: Gastroenterology, Urology
上市路径: 需提交 510(k) 上市前通告

FDA 分类定义

Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections.

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）。

FDA 官方分类页： SCT

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。