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FDA 510(k)

LIFEPAK® 侵入性压力适配器电缆（与ICU Medical Transpack IV侵入性压力传感器（或等效）接口）（11230-000021）；LIFEPAK® 侵入性压力适配器电缆（与Edwards Lifesciences TruWave侵入性压力传感器（或等效）接口）（11230-000024）

K号: K240156 · 2024-04-30

申请人Physio-Control, Inc.
决定日期2024-04-30
产品代码DSA
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： --- 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

LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control, Inc.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K240156. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)?

LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Physio-Control, Inc.. The 510(k) number is K240156.

When did LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) receive FDA 510(k) clearance?

LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) received FDA 510(k) clearance on 2024-04-30, under 510(k) number K240156.

Who is the listed applicant for LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)?

The FDA 510(k) record lists Physio-Control, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)?

The FDA product code for LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) is DSA.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Physio-Control, 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。

K253099LIFEPAK 15 AC电源适配器（41577-000333）K182503用于LIFEPAK除颤器/监护仪的灭菌内部除颤电极

相关器械（代码：DSA）

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。

K254114Baylis 连接器电缆Baylis Medical Technologies, Inc.K252827IBP电缆Becton Dickinson（2606488）；IBP电缆Edwards（2606489）；IBP电缆Abbott, Medex（2606490）；IBP电缆Utah（2606491）；IBP适配器电缆Draeger 7针（2607558）；IBP适配器电缆Draeger 10针（2607559）Drägerwerk AG & Co. KGaAK251669IBP传感器适配器电缆，Argon/BD/Ohmeda，2米；IBP传感器适配器电缆，Draeger 10针，2米；IBP传感器适配器电缆，Draeger 7针，2米；IBP传感器适配器电缆，Abbott/Medex，Smiths/TranStar 2米；IBP传感器适配器电缆，Baxter/Edwards，0.3米；IBP传感器适配器电缆，Baxter/Edwards，2米；IBP传感器适配器电缆，Argon/BD/Ohmeda，0.3米；IBP传感器适配器电缆，Draeger 10针，0.3米；IBP传感器适配器电缆，Draeger 7针，0.3米；IBP传感器适配器Shanghai Draeger Medical Instrument Co., Ltd.K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.K243545Philips可重复使用的ECG导联线和主干电缆：型号编号、型号名称：989803170171，或3导联ECG主干电缆，AAMI/IEC；989803170181，或5导联ECG主干电缆，AAMI/IEC；M1667A，6导联ECG主干，AAMI/IEC 2.7米；M1668A，5导联ECG主干，AAMI/IEC 2.7米；M1669A，3导联ECG主干，AAMI/IEC 2.7米；M1949A，5+5 ECG主干电缆 AAMI，IEC 2.7米；M1663A，10导联ECG主干 AAMI/IEC 2米；M1665A，6+4导联ECG主干 AAMI/IEC 2.7米；M1671A，3导联，抓取器，AAMI，ICU；M1673A，3导联，SnPhilips Medizin Systeme Böblingen GmbHK240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.

官方来源

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