FDA 510(k)

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

K号: K190106 · 2019-06-24

决定日期2019-06-24

产品代码DQK

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle 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 2019-06-24 under 510(k) number K190106. 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; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle?

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle is a medical device that received FDA 510(k) clearance on 2019-06-24. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K190106.

When did Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle receive FDA 510(k) clearance?

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle received FDA 510(k) clearance on 2019-06-24, under 510(k) number K190106.

Who is the listed applicant for Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle?

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; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle?

The FDA product code for Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle 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）K243842术中定位系统（IOPS®）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)

官方来源

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