K240366

EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter

510(k) 号: K240366
器械名称: EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
申请人: Boston Scientific Corporation MN · US
产品代码: DRF — Catheter, Electrode Recording, Or Probe, Electrode R
批准日期: 2024-11-01
受理日期: 2024-02-06
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 · 0.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K240366.pdf

FDA 官方记录： K240366

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。