ICHOR 7F 吸栓系统（ICH-7F）
K号: K233917 · 2024-07-18
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申请人Ichor
决定日期2024-07-18
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
ICHOR 7F Embolectomy System (ICH-7F) is the device name listed in this FDA 510(k) record. The listed applicant is Ichor. It received FDA 510(k) clearance on 2024-07-18 under 510(k) number K233917. 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 ICHOR 7F Embolectomy System (ICH-7F)?
ICHOR 7F Embolectomy System (ICH-7F) is a medical device that received FDA 510(k) clearance on 2024-07-18. The listed applicant is Ichor. The 510(k) number is K233917.
When did ICHOR 7F Embolectomy System (ICH-7F) receive FDA 510(k) clearance?
ICHOR 7F Embolectomy System (ICH-7F) received FDA 510(k) clearance on 2024-07-18, under 510(k) number K233917.
Who is the listed applicant for ICHOR 7F Embolectomy System (ICH-7F)?
The FDA 510(k) record lists Ichor as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ICHOR 7F Embolectomy System (ICH-7F)?
The FDA product code for ICHOR 7F Embolectomy System (ICH-7F) 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Ichor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。
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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