K241683

Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314

510(k) 号: K241683
器械名称: Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314
申请人: Boston Scientific Corporation MN · US
产品代码: LIT — Catheter, Angioplasty, Peripheral, Transluminal
批准日期: 2024-07-10
受理日期: 2024-06-11
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 · 1.7 MB · FDA 公有领域文件

也可从 FDA 官方下载： K241683.pdf

FDA 官方记录： K241683

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。