K241352

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

510(k) 号: K241352
器械名称: Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
申请人: Medtronic, Inc. MN · US
产品代码: DTZ — Oxygenator, Cardiopulmonary Bypass
批准日期: 2024-06-12
受理日期: 2024-05-13
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Cardiovascular

PDF下载 510(k) Summary本站存档 · 1.1 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241352.pdf

FDA 官方记录： K241352

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。