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FDA 510(k)

Arrow® Endurance® 扩展停留外周导管系统 (EDC-00818)

K号: K243599 · 2025-03-14

申请人Arrow International, LLC (A subsidiary of Teleflex, Inc.)
决定日期2025-03-14
产品代码FOZ
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K243599. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Arrow International, LLC (A subsidiary of Teleflex, Inc.). The 510(k) number is K243599.

When did Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) receive FDA 510(k) clearance?

Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243599.

Who is the listed applicant for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

The FDA 510(k) record lists Arrow International, LLC (A subsidiary of Teleflex, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)?

The FDA product code for Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) is FOZ.

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Arrow International, LLC (A subsidiary of Teleflex, 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。

K242281Arrow Endurance 扩展停留外周导管系统 (EDC-00620)；Arrow Endurance 扩展停留外周导管系统 (EDC-00622)；Arrow Endurance 扩展停留外周导管系统 (EDC-00820)；Arrow Endurance 扩展停留外周导管系统 (EDC-00822)K220280Arrow 增硬式芯棒K220363VPS节律DLX设备，配备TipTracker技术

相关器械（代码：FOZ）

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。

K260432Ruby 介入导管Venocare, Inc.K260165未浸渍中心静脉导管Spectrum VascularK261041ClearSafe封闭系统MedSource Labs, LLCK260539MedSource QuickSafe™ 安全静脉留置针；MedSource PurSafe™ 安全静脉留置针MedSource Labs, LLCK253235Introcan Safety® 深部接入 XL 静脉留置针B.Braun Medical, Inc.K252137BD Insyte™ IV 管套Becton Dickinson Infusion Therapy Systems, Inc.

官方来源

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