SEL

Securement Wound Dressing For Reduction Of Infection

产品代码
SEL
器械名称
Securement Wound Dressing For Reduction Of Infection
管理类别
第 U 类(Unclassified)
FDA 专业组
Unknown
上市路径
需提交 510(k) 上市前通告
FDA 历史累计 510(k)
3 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

These dressings are intended to be placed over a vascular or percutaneous device (e.g., needle, catheter, drain) to keep it securely anchored to the skin, cover and protect the insertion site, and may additionally absorb exudate. When used to secure central venous or arterial catheters, a securement wound dressing for reduction of infection is intended to reduce microbial colonization around the insertion site and reduce the incidence of catheter-related bloodstream infections (CRBSI).

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: SEL
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。