FDA 510(k)

EKOS+ 内血管设备

K号: K220866 · 2022-04-20

决定日期2022-04-20

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

EKOS+ 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 2022-04-20 under 510(k) number K220866. 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 EKOS+ Endovascular Device?

EKOS+ Endovascular Device is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Boston Scientific. The 510(k) number is K220866.

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

EKOS+ Endovascular Device received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220866.

Who is the listed applicant for 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 EKOS+ Endovascular Device?

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

列明Boston Scientific为申报人的其他记录

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