K243941

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)

510(k) 号: K243941
器械名称: HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)
申请人: Access Vascular, Inc. MA · US
产品代码: LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
批准日期: 2025-01-17
受理日期: 2024-12-20
决定: Substantially Equivalent
审查途径: Special
咨询委员会: General Hospital

PDF下载 510(k) Summary本站存档 · 2.3 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243941.pdf

FDA 官方记录： K243941

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。