FDA 510(k)

SelectFlex 神经血管通路系统系列

K号: K230322 · 2023-06-22

决定日期2023-06-22

产品代码QJP

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

SelectFlex Neurovascular Access System Family is the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K230322. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SelectFlex Neurovascular Access System Family?

SelectFlex Neurovascular Access System Family is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Q'Apel Medical, Inc.. The 510(k) number is K230322.

When did SelectFlex Neurovascular Access System Family receive FDA 510(k) clearance?

SelectFlex Neurovascular Access System Family received FDA 510(k) clearance on 2023-06-22, under 510(k) number K230322.

Who is the listed applicant for SelectFlex Neurovascular Access System Family?

The FDA 510(k) record lists Q'Apel Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SelectFlex Neurovascular Access System Family?

The FDA product code for SelectFlex Neurovascular Access System Family is QJP.

列明Q'Apel Medical, Inc.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。

K254276Lynx 吸引导管系统 K240746神经血管通路系统系列 K222786072吸引系统 K211893SelectFlex 神经血管通路系统系列

官方来源

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