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FDA 510(k)

EKOS PE 内血管设备带控制系统 4.0 (CS4.0)

K号: K200648 · 2020-08-17

申请人Ekos Corporation
决定日期2020-08-17
产品代码QEY
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ekos Corporation. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K200648. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Ekos Corporation. The 510(k) number is K200648.

When did EKOS PE Endovascular Device with Control System 4.0 (CS4.0) receive FDA 510(k) clearance?

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) received FDA 510(k) clearance on 2020-08-17, under 510(k) number K200648.

Who is the listed applicant for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

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

What is the FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

The FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is QEY.

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

相关器械（代码：QEY）

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。

K260149Versus™ 导管（VS110-9NB）Liquet Medical, Inc.K251318VariFuse 可调式输液导管Argon Medical Devices, Inc.K241851Versus™ 导管（VS110-8B）Liquet Medical, Inc.K231653BASHIR™ .035 内窥镜导管，BASHIR™ S-B .035 内窥镜导管Thrombolex, Inc.K222095BASHIR 内窥镜导管参考编号 7201，BASHIR S-B 内窥镜导管，参考编号 7101Thrombolex, Inc.K220866EKOS+ 内血管设备Boston Scientific

官方来源

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