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FDA 510(k)

V-Grip脱附控制器，用于与Hydrocoil栓塞系统和MicroPlex线圈系统配合使用，AZUR脱附控制器，用于与AZUR周围线圈系统配合使用

K号: K162999 · 2017-03-29

申请人MicroVention, Inc.
决定日期2017-03-29
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

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2017-03-29 under 510(k) number K162999. 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 V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System is a medical device that received FDA 510(k) clearance on 2017-03-29. The listed applicant is MicroVention, Inc.. The 510(k) number is K162999.

When did V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System receive FDA 510(k) clearance?

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System received FDA 510(k) clearance on 2017-03-29, under 510(k) number K162999.

Who is the listed applicant for V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

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

What is the FDA product code for V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System?

The FDA product code for V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil 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MicroVention, 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。

K232542楔形XL输送导管K230775SOFIA EX颅内支撑导管K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222115ISAAC 神经血管导航导管K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88导管

查看所有 24 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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