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FDA 510(k)

Quantum 灌注离心血泵 CP37 集成传感器（CP37V-VT）；Quantum 灌注离心血泵 CP22 集成传感器（CP22V-VT）

K号: K233091 · 2023-10-26

申请人Qura S.R.L
决定日期2023-10-26
产品代码KFM
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

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K233091. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)?

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Qura S.R.L. The 510(k) number is K233091.

When did Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) receive FDA 510(k) clearance?

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) received FDA 510(k) clearance on 2023-10-26, under 510(k) number K233091.

Who is the listed applicant for Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)?

The FDA 510(k) record lists Qura S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) is KFM.

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Qura S.R.L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。

K231982Quantum 灌注血氧器 VT75-E1，Quantum 灌注血氧器 VT75-E2K231773Quantum 灌注血氧器集成的AF和传感器 VT75-C1U，Quantum 灌注血氧器集成的AF VT75-C2U，Quantum 灌注血氧器集成的AF和传感器 VT200-C1U，Quantum 灌注血氧器集成的AF VT200-C2U，Quantum 灌注血氧器集成的AF和传感器 VT160-C1UK220842Quantum 灌注离心血泵 CP22 集成传感器，Quantum 灌注离心血泵 CP20 集成传感器K221353Quantum 灌注双腔导管 31F，Quantum 灌注双腔导管 27F，Quantum 灌注双腔导管 24F，Quantum 灌注双腔导管 29F，Quantum 灌注双腔导管 24F-V1，Quantum 灌注双腔导管 27F-V1，Quantum 灌注双腔导管 29F-V1，Quantum 灌注双腔导管 27F-VS，Quantum 灌注双腔导管 31F-VSK213540Quantum SuperPAC 管道套装, Quantum SuperPAC 心肌停搏套装K220110Quantum PureFlow 标准热交换器和 Quantum PureFlow 心肌停搏热交换器

查看所有 15 个设备 →

相关器械（代码：KFM）

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。

K251762Quantum 灌注离心血泵 CP20NG 集成传感器（CP20V-NG）Spectrum Medical S.R.L.K250326Quantum 灌注离心血泵 CP22NG 集成传感器（CP22V-NG）Spectrum Medical S.R.L.K232132LifeSPARC 系统Cardiacassist, Inc.K220842Quantum 灌注离心血泵 CP22 集成传感器，Quantum 灌注离心血泵 CP20 集成传感器Qura S.R.LK200091Capiox iCP 离心泵Terumo Cardiovascular Systems CorporationK201320Quantum PureFlow 离心血泵 CP22 集成传感器Qura S.R.L

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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