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FDA 510(k)

OptiCross 6, 40 MHz 冠状动脉成像导管（美国分销），OptiCross 6, 40 MHz 冠状动脉成像导管（欧洲分销），OptiCross 6, 40 MHz 冠状动脉成像导管（洲际分销）

K号: K153617 · 2016-02-25

申请人Boston Scientific Corporation
决定日期2016-02-25
产品代码OBJ
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

OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153617. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)?

OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Boston Scientific Corporation. The 510(k) number is K153617.

When did OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) receive FDA 510(k) clearance?

OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153617.

Who is the listed applicant for OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)?

The FDA product code for OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) is OBJ.

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Boston Scientific Corporation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。

K262151SpaceOAR Flex™ 系统K261153LithoVue Elite 数字柔性输尿管镜系统K261915Navigator™ Flex 肾盂输尿管通路鞘套装K262165FARADRIVE™ 导向鞘（M004PF21M402）K262462TheraSphere 360® Y-90管理平台K261488OBSIDIO 可变形栓塞

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相关器械（代码：OBJ）

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。

K261696ACUNAV Luxera 4D ICE 球囊导管Siemens Medical Solutions USA, Inc.K261849VEFAYE成像导管（VF-VIC-002）Luma Vision LimitedK252945Novasight 混合系统Conavi Medical, Inc.K260816OptiCross 冠状动脉成像导管（H749518110）；OptiCross 6 冠状动脉成像导管（H7495181160）；OptiCross HD 冠状动脉成像导管（H74939352040）；OptiCross 6 HD 冠状动脉成像导管（H74939354080）；OptiCross 冠状动脉成像导管（无袋）（H749518130）；OptiCross 6 冠状动脉成像导管（无袋）（H7495181360）；OptiCross HD 冠状动脉成像导管（无袋）（H74939352050）；OptiCross 6 HD 冠状动脉成像导管（无袋）（H74939354090）Boston ScientificK253399Visions® PV .014P RX 数字IVUS导管；Visions® PV .018 数字IVUS导管Volcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 冰冻系统，美国Yorlabs, Inc.

官方来源

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