靛蓝吸引系统 - 闪电闪光
K号: K222358 · 2022-12-20
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决定日期2022-12-20
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：
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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]
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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 - Lightning Flash is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K222358. 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 - Lightning Flash?
Indigo Aspiration System - Lightning Flash is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Penumbra, Inc.. The 510(k) number is K222358.
When did Indigo Aspiration System - Lightning Flash receive FDA 510(k) clearance?
Indigo Aspiration System - Lightning Flash received FDA 510(k) clearance on 2022-12-20, under 510(k) number K222358.
Who is the listed applicant for Indigo Aspiration System - Lightning Flash?
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 - Lightning Flash?
The FDA product code for Indigo Aspiration System - Lightning Flash 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。
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）
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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