FDA 510(k)

Penumbra 系统（再灌注导管 RED 72）

K号: K242104 · 2025-02-13

决定日期2025-02-13

产品代码NRY

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

Penumbra System (Reperfusion Catheter RED 72) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K242104. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Penumbra System (Reperfusion Catheter RED 72)?

Penumbra System (Reperfusion Catheter RED 72) is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Penumbra, Inc.. The 510(k) number is K242104.

When did Penumbra System (Reperfusion Catheter RED 72) receive FDA 510(k) clearance?

Penumbra System (Reperfusion Catheter RED 72) received FDA 510(k) clearance on 2025-02-13, under 510(k) number K242104.

Who is the listed applicant for Penumbra System (Reperfusion Catheter RED 72)?

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

What is the FDA product code for Penumbra System (Reperfusion Catheter RED 72)?

The FDA product code for Penumbra System (Reperfusion Catheter RED 72) is NRY.

列明Penumbra, 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。

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