PTN

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

产品代码: PTN
器械名称: Reservoir, Blood, Cardiopulmonary Bypass, Exempt
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 870.4400
FDA 专业组: Cardiovascular
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

This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

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： PTN

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。