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FDA 510(k)

Penumbra 撕离吸引系统 (INDIGOTM 吸引系统)

K号: K160533 · 2016-05-24

申请人Penumbra, Inc.
决定日期2016-05-24
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

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) number K160533. 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 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is a medical device that received FDA 510(k) clearance on 2016-05-24. The listed applicant is Penumbra, Inc.. The 510(k) number is K160533.

When did Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) receive FDA 510(k) clearance?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) received FDA 510(k) clearance on 2016-05-24, under 510(k) number K160533.

Who is the listed applicant for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

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 Embolectomy Aspiration System (INDIGOTM Aspiration System)?

The FDA product code for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) 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）K260599INDIGO® Aspiration System – INDIGO LinkK251949INDIGO® 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）

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 EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.

官方来源

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