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FDA 510(k)

HDX 100%硅酮双向Foley导尿管，14Fr/10cc，HDX 100%硅酮双向Foley导尿管，16Fr/5cc，HDX 100%硅酮双向Foley导尿管，18Fr/10cc

K号: K192034 · 2020-04-21

申请人Pathway, LLC
决定日期2020-04-21
产品代码EZL
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc is the device name listed in this FDA 510(k) record. The listed applicant is Pathway, LLC. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K192034. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc?

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Pathway, LLC. The 510(k) number is K192034.

When did HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc receive FDA 510(k) clearance?

HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192034.

Who is the listed applicant for HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc?

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

What is the FDA product code for HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc?

The FDA product code for HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc is EZL.

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Pathway, LLC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。

K181616PSM 3-通路硅胶 Foley 导尿管K162233Kurin血液培养收集套装

相关器械（代码：EZL）

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。

K260756创伤卫士腹部压力感应系统（000-0221）Sentinel Medical Technologies,K262056Rusch 液体金福来尿管Teleflex Medical Sdn. Bhd.K252537Rusch 软塑 Foley 导尿管Teleflex Medical Sdn. Bhd.K243011硅胶尿道导管（硅胶尿道导管）Guangdong Ecan Medical Co., Ltd.K241424InnoCare 专业 Foley 导尿管Innocare Urologics, LLCK232469Rüsch 橡胶金 Foley 导尿管Teleflexmedical, Inc.

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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