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FDA 510(k)

TracStar 大型远端平台，ZOOM 88 大型远端平台，ZOOM 88-T 大型远端平台

K号: K203764 · 2021-03-03

申请人Imperative Care, Inc.
决定日期2021-03-03
产品代码QJP
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

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K203764. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Imperative Care, Inc.. The 510(k) number is K203764.

When did TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform receive FDA 510(k) clearance?

TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform received FDA 510(k) clearance on 2021-03-03, under 510(k) number K203764.

Who is the listed applicant for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

FDA 510(k)记录将Imperative Care, Inc.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform?

The FDA product code for TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform is QJP.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Imperative Care, 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。

K261176Zoom 4S 导管K252046Zoom系统（Zoom 4S导管）K252057Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统K244061X-Wire 导丝K243047Zoom 7X 导管；Zoom 吸痰管；Zoom POD 吸痰管K250775Symphony™ 血栓切除术系统；Symphony™ 16F 82cm 血栓切除术系统

查看所有 18 个设备 →

相关器械（代码：QJP）

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。

K26022092医疗全长046接入系统Route 92 Medical, Inc.K26227770 NeuGlide 导管Piraeus Medical, Inc.K261176Zoom 4S 导管Imperative Care, Inc.K254071p17 XR 微导管Wallaby MedicalK260199SLIM 微导管Balt USA, LLCK253901Millipede88接入导管Perfuze, Ltd.

官方来源

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