K251291

Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers

510(k) 号: K251291
器械名称: Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
申请人: Boston Scientific MA · US
产品代码: FGE — Stents, Drains And Dilators For The Biliary Ducts
批准日期: 2025-07-03
受理日期: 2025-04-25
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

也可从 FDA 官方下载： K251291.pdf

FDA 官方记录： K251291

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。