NOO
- 产品代码
- NOO
- 器械名称
- Clamp, Dialysis Arm
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 876.5540
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
FDA 分类定义
The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.
FDA 官方分类页： NOO
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。