K234046

WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System

510(k) 号: K234046
器械名称: WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
申请人: Boston Scientific Corporation MA · US
产品代码: MQR — Stent, Colonic, Metallic, Expandable
批准日期: 2024-03-08
受理日期: 2023-12-21
决定: Substantially Equivalent
审查途径: Special
咨询委员会: General, Plastic Surgery

PDF下载 510(k) Summary本站存档 · 1.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K234046.pdf

FDA 官方记录： K234046

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。