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FDA 510(k)

Ellipsys 血管通路系统 (Ellipsys 系统)，功率控制器，Ellipsys 血管通路系统 (Ellipsys 系统)，导管，Ellipsys 血管通路系统 (Ellipsys 系统)，针

K号: K191114 · 2019-08-09

申请人Avenu Medical
决定日期2019-08-09
产品代码PQK
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

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is the device name listed in this FDA 510(k) record. The listed applicant is Avenu Medical. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K191114. The device is classified under product code PQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Avenu Medical. The 510(k) number is K191114.

When did Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle receive FDA 510(k) clearance?

Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191114.

Who is the listed applicant for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

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

What is the FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle?

The FDA product code for Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle is PQK.

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：PQK）

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。

K192239WavelinQ Plus 内科AVF系统C.R. Bard, Inc.K182796WavelinQ 4F 内窥镜AVF系统C.R. Bard, Inc.K183615Ellipsys 血管通路系统 (Ellipsys 系统)，功率控制器，Ellipsys 血管通路系统 (Ellipsys 系统)，导管，Ellipsys 血管通路系统 (Ellipsys 系统)，交叉针Avenu Medical, Inc.K181725Ellipsys 血管通路系统 (Ellipsys 系统)，（功率控制器型号 AMI-1001 & 导管 & 针型号 AMI-6005）Avenu Medical, Inc.

官方来源

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