K242705

Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)

510(k) 号: K242705
器械名称: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
申请人: Medtronic, Inc. MN · US
产品代码: LDF — Electrode, Pacemaker, Temporary
批准日期: 2025-01-17
受理日期: 2024-09-09
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 · 0.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242705.pdf

FDA 官方记录： K242705

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。