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FDA 510(k)

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS

K号: K212057 · 2022-03-01

申请人Artventive Medical Group, Inc.
决定日期2022-03-01
产品代码KRD
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

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is the device name listed in this FDA 510(k) record. The listed applicant is Artventive Medical Group, Inc.. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K212057. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Artventive Medical Group, Inc.. The 510(k) number is K212057.

When did Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS receive FDA 510(k) clearance?

Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS received FDA 510(k) clearance on 2022-03-01, under 510(k) number K212057.

Who is the listed applicant for Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

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

What is the FDA product code for Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS?

The FDA product code for Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS is KRD.

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：KRD）

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。

K252812UniPearls® 颗粒性栓塞微球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可变形栓塞Boston Scientific CorporationK261866Concerto Versa® 可拆卸线圈Medtronic, Inc.K260635HARBOR 阻塞装置Nuvascular, Inc.K260508LOBO 血管闭塞系统Okami Medical, Inc.K253511Concerto Versa® 可拆卸线圈Medtronic, Inc.

官方来源

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