PIN Kidney Perfusion Kit · FDA 产品代码

Kidney Perfusion Kit

产品代码: PIN
器械名称: Kidney Perfusion Kit
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 876.5880
FDA 专业组: Gastroenterology, Urology
上市路径: Enforcement Discretion

FDA 分类定义

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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： PIN

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。