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FDA 510(k)

Quantum 灌注单腔导管 22F，Quantum 灌注双腔导管 31F，Quantum 灌注双腔导管 27F，Quantum 灌注双腔导管 24F

K号: K203067 · 2021-11-08

申请人Qura S.R.L
决定日期2021-11-08
产品代码DWF
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 Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F 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 2021-11-08 under 510(k) number K203067. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F?

Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F is a medical device that received FDA 510(k) clearance on 2021-11-08. The listed applicant is Qura S.R.L. The 510(k) number is K203067.

When did Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F receive FDA 510(k) clearance?

Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F received FDA 510(k) clearance on 2021-11-08, under 510(k) number K203067.

Who is the listed applicant for Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F?

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 Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F?

The FDA product code for Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F is DWF.

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：DWF）

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。

K260195延长型单件动脉（EOPA）3D® 动脉导管Medtronic, Inc.K250937静脉回流导管LivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203逆行冠状动脉窦灌注导管Medtronic, Inc.K253671双阶段静脉导管Sorin Group Italia S.R.L.K253998Clearview 冠状动脉内分流管Medtronic, Inc.

官方来源

在 FDA 数据库中查看 →

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