K251181

Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

510(k) 号: K251181
器械名称: Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)
申请人: Merit Medical Ireland, Ltd. IE
产品代码: DQX — Wire, Guide, Catheter
批准日期: 2025-08-29
受理日期: 2025-04-16
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 · 3.1 MB · FDA 公有领域文件

也可从 FDA 官方下载： K251181.pdf

FDA 官方记录： K251181

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。