FDA 510(k)

EkoSonic Endovascular System with Control Unit 4.0

K号: K162771 · 2017-02-24

决定日期2017-02-24

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

EkoSonic Endovascular System with Control Unit 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Btg International, Inc.. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162771. 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 EkoSonic Endovascular System with Control Unit 4.0?

EkoSonic Endovascular System with Control Unit 4.0 is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Btg International, Inc.. The 510(k) number is K162771.

When did EkoSonic Endovascular System with Control Unit 4.0 receive FDA 510(k) clearance?

EkoSonic Endovascular System with Control Unit 4.0 received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162771.

Who is the listed applicant for EkoSonic Endovascular System with Control Unit 4.0?

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

What is the FDA product code for EkoSonic Endovascular System with Control Unit 4.0?

The FDA product code for EkoSonic Endovascular System with Control Unit 4.0 is QEY.

列明Btg International, 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。

K191119EkoSonic Endovascular Device K183361EkoSonic Endovascular Device with Control Unit 4.0 K182324EkoSonic Endovascular System K172035EKOS 超声 EVD 设备，EVD 控制单元

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。