K261529

Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)

510(k) 号: K261529
器械名称: Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
申请人: Hartman Medical Group, LLC AL · US
产品代码: DYB — Introducer, Catheter
批准日期: 2026-07-06
受理日期: 2026-05-08
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： K261529.pdf

FDA 官方记录： K261529

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。