CARDIOSAVE主动脉球囊泵
K号: K181122 · 2018-05-31
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决定日期2018-05-31
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
CARDIOSAVE Intra-Aortic Balloon Pump is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2018-05-31 under 510(k) number K181122. 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 CARDIOSAVE Intra-Aortic Balloon Pump?
CARDIOSAVE Intra-Aortic Balloon Pump is a medical device that received FDA 510(k) clearance on 2018-05-31. The listed applicant is Datascope Corp.. The 510(k) number is K181122.
When did CARDIOSAVE Intra-Aortic Balloon Pump receive FDA 510(k) clearance?
CARDIOSAVE Intra-Aortic Balloon Pump received FDA 510(k) clearance on 2018-05-31, under 510(k) number K181122.
Who is the listed applicant for CARDIOSAVE Intra-Aortic Balloon Pump?
The FDA 510(k) record lists Datascope Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CARDIOSAVE Intra-Aortic Balloon Pump?
The FDA product code for CARDIOSAVE 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Datascope Corp.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, LLCK232343AC3® 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.
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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