FDA 510(k)

Penumbra 系统（Thunderbolt 吸引导管）

K号: K250690 · 2026-06-10

决定日期2026-06-10

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 (Thunderbolt Aspiration Tubing) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K250690. 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 (Thunderbolt Aspiration Tubing)?

Penumbra System (Thunderbolt Aspiration Tubing) is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Penumbra, Inc.. The 510(k) number is K250690.

When did Penumbra System (Thunderbolt Aspiration Tubing) receive FDA 510(k) clearance?

Penumbra System (Thunderbolt Aspiration Tubing) received FDA 510(k) clearance on 2026-06-10, under 510(k) number K250690.

Who is the listed applicant for Penumbra System (Thunderbolt Aspiration Tubing)?

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 (Thunderbolt Aspiration Tubing)?

The FDA product code for Penumbra System (Thunderbolt Aspiration Tubing) 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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官方来源

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