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FDA 510(k)

IRRAflow 导管，IRRAflow 管道套装，IRRAflow 控制单元

K号: K200807 · 2020-04-29

申请人Irras USA, Inc.
决定日期2020-04-29
产品代码JXG
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决定实质等同

器械摘要

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is the device name listed in this FDA 510(k) record. The listed applicant is Irras USA, Inc.. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K200807. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Irras USA, Inc.. The 510(k) number is K200807.

When did IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit receive FDA 510(k) clearance?

IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit received FDA 510(k) clearance on 2020-04-29, under 510(k) number K200807.

Who is the listed applicant for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

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

What is the FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit?

The FDA product code for IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit is JXG.

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Irras USA, 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。

K231664IRRAflow Active Fluid Exchange System (AFES)

相关器械（代码：JXG）

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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini 单压力阀 (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís分流导管，带Bactiseal和Endexo技术Integra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）Integra Lifesciences Production Corporation

官方来源

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