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FDA 510(k)

MICRUSFRAME 10 抗拉伸微线圈输送系统，MICRUSFRAME 18 抗拉伸微线圈输送系统，DELTAFILL 18 抗拉伸微线圈输送系统，DELTAXSFT 10 抗拉伸微线圈输送系统，GALAXY G3 FILL 和 GALAXY G3 XSFT 抗拉伸微线圈输送系统

K号: K171747 · 2017-07-14

申请人Codman & Shurtleff, Inc.
决定日期2017-07-14
产品代码HCG
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K171747. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K171747.

When did MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System receive FDA 510(k) clearance?

MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K171747.

Who is the listed applicant for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

The FDA 510(k) record lists Codman & Shurtleff, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System?

The FDA product code for MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System is HCG.

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Codman & Shurtleff, 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。

K193380CERENOVUS大口径导管；CERENOVUS吸引管套装K191237CERENOVUS大口径导管K173192CereLink ICP 传感器基本套件，CereLink ICP 传感器金属颅骨螺栓套件，CereLink ICP 传感器塑料颅骨螺栓套件，CereLink ICP 传感器心室导管套件K172537Codman EDS 3 CSF外部引流系统，Codman EDS 3 CSF外部引流系统收集袋K172022CODMAN脑积水阀门、导管及配件（捆绑）K171862GALAXY G3 Mini 微线圈输送系统

查看所有 11 个设备 →

相关器械（代码：HCG）

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。

K262419MICRUSFRAME（MFR100202）；MICRUSFRAME（MFR100253）；MICRUSFRAME（MFR100305）；MICRUSFRAME（MFR100356）；MICRUSFRAME（MFR100407）；MICRUSFRAME（MFR100412）；MICRUSFRAME（MFR100509）；MICRUSFRAME（MFR100517）；MICRUSFRAME（MFR100611）；MICRUSFRAME（MFR100626）；MICRUSFRAME（MFR100713）；MICRUSFRAME（MFR100730）；MICRUSFRAME（MFR100816）；MICRUSFRAME（MFR100829）；MICRUSFRAME（MFR140225）；MICRUSFRAME（MFR140303）；MICRUSFRAME（MFR140304）；MICRUSFRAME（MFR140306）；MICRUSFRAME（MFR140406）；MICRUSFRAME（MFCerenovus, Inc.K261772目标Xtra可拆卸线圈Stryker NeurovscularK260351Numen® Helia 球囊栓塞系统；NumenFR® 分离系统MicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima线圈系统（OptiOne线圈系统）Balt USA, LLCK252694目标可拆卸线圈Stryker NeurovascularK251832InZone IST 分离系统；IZDS 连接电缆Stryker Neurovascular

官方来源

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