FDA 510(k)

术中定位系统（IOPS®）

K号: K243842 · 2025-03-06

决定日期2025-03-06

产品代码DQK

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决定实质等同

器械摘要

Intra-Operative Positioning System (IOPS®) is the device name listed in this FDA 510(k) record. The listed applicant is Centerline Biomedical, Inc.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243842. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intra-Operative Positioning System (IOPS®)?

Intra-Operative Positioning System (IOPS®) is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K243842.

When did Intra-Operative Positioning System (IOPS®) receive FDA 510(k) clearance?

Intra-Operative Positioning System (IOPS®) received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243842.

Who is the listed applicant for Intra-Operative Positioning System (IOPS®)?

The FDA 510(k) record lists Centerline Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intra-Operative Positioning System (IOPS®)?

The FDA product code for Intra-Operative Positioning System (IOPS®) is DQK.

列明Centerline Biomedical, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254089IOPS 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）K242133术中定位系统（IOPS®）（标记追踪垫）；术中定位系统（IOPS®）（导丝手柄）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）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)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

官方来源

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