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Centerline Biomedical, Inc.

FDA 510(k) & PMA Approved 器械 — 6 products

器械总数6
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) 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）DQK2026-02-17 查看
510(k) K243842 术中定位系统（IOPS®）DQK2025-03-06 查看
510(k) K242133 术中定位系统（IOPS®）（标记追踪垫）；术中定位系统（IOPS®）（导丝手柄）DQK2024-10-11 查看
510(k) K241243 术中定位系统（IOPS®）Viewpoint（简单曲线导管）；术中定位系统（IOPS®）Viewpoint（双曲线导管）DQK2024-07-24 查看
510(k) K230309 术中定位系统（IOPS®）（MC-1）；IOPS Simple Curve Catheter (SCC-1) 和 IOPS Reverse Curve Catheter (RCC-1)；IOPS Guidewire (ATW-2)；IOPS Tracking Pad (TP-1)；IOPS Guidewire Handle (SSH-1)DQK2023-06-21 查看
510(k) K190106 术中定位系统；简单曲线导管，反向曲线导管；角度尖端导丝；追踪垫；导丝手柄DQK2019-06-24 查看
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