K254089

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

510(k) 号: K254089
器械名称: IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
申请人: Centerline Biomedical, Inc. OH · US
产品代码: DQK — Computer, Diagnostic, Programmable
批准日期: 2026-02-17
受理日期: 2025-12-19
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 · 1.0 MB · FDA 公有领域文件

也可从 FDA 官方下载： K254089.pdf

FDA 官方记录： K254089

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。