FDA 510(k)

Sentinel Cerebral Protection System

K号: K192460 · 2020-02-19

决定日期2020-02-19

产品代码PUM

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

Sentinel Cerebral Protection System 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 2020-02-19 under 510(k) number K192460. The device is classified under product code PUM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sentinel Cerebral Protection System?

Sentinel Cerebral Protection System is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is Boston Scientific Corporation. The 510(k) number is K192460.

When did Sentinel Cerebral Protection System receive FDA 510(k) clearance?

Sentinel Cerebral Protection System received FDA 510(k) clearance on 2020-02-19, under 510(k) number K192460.

Who is the listed applicant for Sentinel Cerebral Protection System?

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 Sentinel Cerebral Protection System?

The FDA product code for Sentinel Cerebral Protection System is PUM.

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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