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FDA 510(k)

WallFlex 结肠软支架系统，配备锚定锁输送系统，WallFlex 十二指肠软支架系统，配备锚定锁输送系统

K号: K200257 · 2020-04-17

申请人Boston Scientific Corporation
决定日期2020-04-17
产品代码MQR
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System 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 2020-04-17 under 510(k) number K200257. The device is classified under product code MQR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System?

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K200257.

When did WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System receive FDA 510(k) clearance?

WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200257.

Who is the listed applicant for WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System?

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 WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System?

The FDA product code for WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is MQR.

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

查看所有 167 个设备 →

相关器械（代码：MQR）

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。

K234046WallFlex 结肠支架系统带锚定锁输送系统；WallFlex 十二指肠支架系统带锚定锁输送系统；WallFlex 结肠软支架系统带锚定锁输送系统；WallFlex 十二指肠软支架系统带锚定锁输送系统Boston Scientific CorporationK201159WallFlex 结肠支架系统带锚定锁输送系统Boston Scientific CorporationK190141HANAROSTENT 低轴结肠/直肠 (NNN)M.I.Tech Co., Ltd.K183616HANAROSTENT 低轴结肠/直肠 (NNN), HANAROSTENT 低轴十二指肠/幽门 (NNN)M.I.Tech Co., Ltd.K180180HANAROSTENT 低轴TM 结肠/直肠 (NNN), HANAROSTENT 低轴TM 十二指肠/幽门 (NNN)M.I.Tech Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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