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FDA 510(k)

INDIGO® Aspiration System – INDIGO Link

K号: K260599 · 2026-04-24

申请人Penumbra, Inc.
决定日期2026-04-24
产品代码QEW
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

INDIGO® Aspiration System – INDIGO Link is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260599. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the INDIGO® Aspiration System – INDIGO Link?

INDIGO® Aspiration System – INDIGO Link is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Penumbra, Inc.. The 510(k) number is K260599.

When did INDIGO® Aspiration System – INDIGO Link receive FDA 510(k) clearance?

INDIGO® Aspiration System – INDIGO Link received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260599.

Who is the listed applicant for INDIGO® Aspiration System – INDIGO Link?

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 INDIGO® Aspiration System – INDIGO Link?

The FDA product code for INDIGO® Aspiration System – INDIGO Link is QEW.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K250690Penumbra 系统（Thunderbolt 吸引导管）K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKK252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration TubingK250079Ruby XL 系统K242104Penumbra 系统（再灌注导管 RED 72）K242033Access25® 输送微导管

查看所有 60 个设备 →

相关器械（代码：QEW）

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。

K253419Triever Duo 导管Inari Medical, Inc.K261800Helo Max血栓切除术系统（HEL2090）Endovascular EngineeringK262538Artix™ MT；Artix™薄壁套管Inari Medical, Inc.K261523Vertex™ 血栓切除术系统Jupiter EndovascularK251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K260028CLEANER® 真空血栓切除术系统，CLEANER® 真空吸引导管手柄，CLEANER® 真空吸引罐Argon Medical Devices, Inc.

官方来源

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