K240666

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

510(k) 号: K240666
器械名称: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
申请人: Medtronic Perfusion Systems MN · US
产品代码: DTZ — Oxygenator, Cardiopulmonary Bypass
批准日期: 2024-07-10
受理日期: 2024-03-08
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Cardiovascular

PDF下载 510(k) Summary本站存档 · 1.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K240666.pdf

FDA 官方记录： K240666

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。