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FDA 510(k)

Quantum 灌注血氧器 ECC VT200-E1，Quantum 灌注血氧器 ECC VT200-E2，Quantum 灌注血氧器 ECC VT160-E1，Quantum 灌注血氧器 ECC VT160-E2

K号: K203424 · 2021-12-17

申请人Qura S.R.L
决定日期2021-12-17
产品代码DTZ
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 Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 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 2021-12-17 under 510(k) number K203424. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2?

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Qura S.R.L. The 510(k) number is K203424.

When did Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 receive FDA 510(k) clearance?

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 received FDA 510(k) clearance on 2021-12-17, under 510(k) number K203424.

Who is the listed applicant for Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2?

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 Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2?

The FDA product code for Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 is DTZ.

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-C1UK233091Quantum 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）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

查看所有 15 个设备 →

相关器械（代码：DTZ）

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。

K261438HORIZON 8AF（集成OXY模块8AF和HORIZON CVR）（US5305）Eurosets S.R.LK253838Lifemotion 一次性膜式氧合器Lifemotion Medical Technology Co., Ltd.K240934Quantum 灌注血氧器 ECC VT160-E3（VT160-E3）；Quantum 灌注血氧器 ECC VT200-E3（VT200-E3）；Quantum 灌注血氧器 VT75-E3（VT75-E3）；Spectrum Medical S.R.L.K250821Horizon AF Plus 系统 (集成 A.L. One AF Plus OXYGENATOR 和 Horizon CVR) (US5300)；A.L. One AF Plus OXYGENATOR (US5204)；Horizon CVR (US5073)Eurosets S.R.LK242503Trilly儿童氧合器带集成动脉过滤器（US5232）Eurosets S.R.LK231982Quantum 灌注血氧器 VT75-E1，Quantum 灌注血氧器 VT75-E2Qura 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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