FDA 510(k)

Easi-Vue 血栓微球系统

K号: K220567 · 2022-09-07

决定日期2022-09-07

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

Easi-Vue embolic microspheres System is the device name listed in this FDA 510(k) record. The listed applicant is Abk Biomedical, Inc.. It received FDA 510(k) clearance on 2022-09-07 under 510(k) number K220567. 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 Easi-Vue embolic microspheres System?

Easi-Vue embolic microspheres System is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Abk Biomedical, Inc.. The 510(k) number is K220567.

When did Easi-Vue embolic microspheres System receive FDA 510(k) clearance?

Easi-Vue embolic microspheres System received FDA 510(k) clearance on 2022-09-07, under 510(k) number K220567.

Who is the listed applicant for Easi-Vue embolic microspheres System?

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

What is the FDA product code for Easi-Vue embolic microspheres System?

The FDA product code for Easi-Vue embolic microspheres System is KRD.

列明Abk Biomedical, Inc.为申报人的其他记录

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K234123Easi-Vue® 血栓微球系统

官方来源

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