K233983

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

510(k) 号: K233983
器械名称: Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
申请人: Edwards Lifesciences CA · US
产品代码: DYG — Catheter, Flow Directed
批准日期: 2024-06-27
受理日期: 2023-12-18
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Cardiovascular

510(k) Summary（FDA 官方 PDF）： K233983.pdf

FDA 官方记录： K233983

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。