FDA 510(k)

EkoSonic Endovascular Device

K号: K211080 · 2021-11-19

决定日期2021-11-19

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 Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211080. 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 Device?

EkoSonic Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Boston Scientific. The 510(k) number is K211080.

When did EkoSonic Endovascular Device receive FDA 510(k) clearance?

EkoSonic Endovascular Device received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211080.

Who is the listed applicant for EkoSonic Endovascular Device?

FDA 510(k)记录显示波士顿科学公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for EkoSonic Endovascular Device?

The FDA product code for EkoSonic Endovascular Device is QEY.

列明Boston Scientific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。

查看所有 30 个设备 →

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。