K233668

Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)

510(k) 号: K233668
器械名称: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)
申请人: Eximo Medical, Ltd. IL
产品代码: MCW — Catheter, Peripheral, Atherectomy
批准日期: 2023-12-15
受理日期: 2023-11-15
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 · 2.5 MB · FDA 公有领域文件

也可从 FDA 官方下载： K233668.pdf

FDA 官方记录： K233668

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。