AC3® 范围® 主动脉球囊泵
K号: K250542 · 2025-03-26
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决定日期2025-03-26
产品代码DSP
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
AC3™ Range™ Intra-Aortic Balloon Pump is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K250542. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AC3™ Range™ Intra-Aortic Balloon Pump?
AC3™ Range™ Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Arrow International, LLC. The 510(k) number is K250542.
When did AC3™ Range™ Intra-Aortic Balloon Pump receive FDA 510(k) clearance?
AC3™ Range™ Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2025-03-26, under 510(k) number K250542.
Who is the listed applicant for AC3™ Range™ Intra-Aortic Balloon Pump?
The FDA 510(k) record lists Arrow International, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AC3™ Range™ Intra-Aortic Balloon Pump?
The FDA product code for AC3™ Range™ Intra-Aortic Balloon Pump is DSP.
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Arrow International, LLC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：DSP）
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。
K232343AC3® 系列IABPArrow International, LLCK201112AC3 IABP，AC3 Optimus IABP，AutoCAT2 Wave IABP，AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix 主动脉球囊导管套装Arrow International, Inc.K192238AC3 系列主动脉球囊泵 (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, Inc.K190117Fiberoptix IABArrow International, 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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