FDA 510(k)

WallFlex 结肠支架系统带锚定锁输送系统

K号: K201159 · 2020-08-17

决定日期2020-08-17

产品代码MQR

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决定实质等同

器械摘要

WallFlex Colonic 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 2020-08-17 under 510(k) number K201159. 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 Stent System with Anchor Lock Delivery System?

WallFlex Colonic Stent System with Anchor Lock Delivery System is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K201159.

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

WallFlex Colonic Stent System with Anchor Lock Delivery System received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201159.

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

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

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：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 Corporation K200257WallFlex 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Boston Scientific Corporation K190141HANAROSTENT 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

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