AC3® 系列IABP
K号: K232343 · 2023-08-30
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决定日期2023-08-30
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]
---
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™ Series IABP 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 2023-08-30 under 510(k) number K232343. 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™ Series IABP?
AC3™ Series IABP is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Arrow International, LLC. The 510(k) number is K232343.
When did AC3™ Series IABP receive FDA 510(k) clearance?
AC3™ Series IABP received FDA 510(k) clearance on 2023-08-30, under 510(k) number K232343.
Who is the listed applicant for AC3™ Series IABP?
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™ Series IABP?
The FDA product code for AC3™ Series IABP 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。
K250542AC3® 范围® 主动脉球囊泵Arrow 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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