FDA 510(k)

EkoSonic Endovascular Device, EKOS+ Endovascular Device

K号: K213422 · 2021-12-14

决定日期2021-12-14

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, EKOS+ Endovascular Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K213422. 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, EKOS+ Endovascular Device?

EkoSonic Endovascular Device, EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Boston Scientific Corporation. The 510(k) number is K213422.

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

EkoSonic Endovascular Device, EKOS+ Endovascular Device received FDA 510(k) clearance on 2021-12-14, under 510(k) number K213422.

Who is the listed applicant for EkoSonic Endovascular Device, EKOS+ 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, EKOS+ Endovascular Device?

The FDA product code for EkoSonic Endovascular Device, EKOS+ Endovascular Device is QEY.

列明Boston Scientific Corporation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。

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