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FDA 510(k)

CereLink 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

K号: K173192 · 2017-11-08

申请人Codman & Shurtleff, Inc.
决定日期2017-11-08
产品代码GWM
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

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit 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 2017-11-08 under 510(k) number K173192. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit?

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit is a medical device that received FDA 510(k) clearance on 2017-11-08. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K173192.

When did CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit receive FDA 510(k) clearance?

CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit received FDA 510(k) clearance on 2017-11-08, under 510(k) number K173192.

Who is the listed applicant for CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit?

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 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit?

The FDA product code for CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit is GWM.

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K171747MICRUSFRAME 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

查看所有 11 个设备 →

相关器械（代码：GWM）

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。

K252241Pressio 3多参数神经监测系统SophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C 系统 - 新增传感器型号（BcSs-PICNIW-2000）Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）Integra Lifesciences Production CorporationK201989B4C 系统Braincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP 监测器Integra Lifesciences Production Corporation

官方来源

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