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FDA 510(k)

Advantage/Advantage Fit 输送装置，Lynx 输送装置，Obtryx 输送装置（弯曲 & Halo），Obtryx II 输送装置（弯曲 & Halo），Solyx SIS 输送装置

K号: K172565 · 2017-12-20

申请人Boston Scientific Corporation
决定日期2017-12-20
产品代码PWJ
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device 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 2017-12-20 under 510(k) number K172565. The device is classified under product code PWJ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Boston Scientific Corporation. The 510(k) number is K172565.

When did Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device receive FDA 510(k) clearance?

Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device received FDA 510(k) clearance on 2017-12-20, under 510(k) number K172565.

Who is the listed applicant for Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

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 Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device?

The FDA product code for Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device is PWJ.

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：PWJ）

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。

K181151GYNECARE TVT Abbrevo排尿系统；GYNECARE TVT闭孔排尿系统ETHICON, Inc.K173019GYNECARE TVT可重复使用导引器，GYNECARE TVT可重复使用刚性导管导引器，GYNECARE TVT EXACT排尿系统套管ETHICON, Inc.K173162GYNECARE TVT腹部导引器和连接器，GYNECARE TVT可重复使用导引器，GYNECARE TVT可重复使用刚性导管导引器ETHICON, Inc.K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, LeftCaldera Medical, Inc.

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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