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FDA 510(k)

EsoFLIP® ES-310 Balloon Catheter

K号: K172128 · 2017-11-22

申请人Crospon, Ltd.
决定日期2017-11-22
产品代码PIE
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

EsoFLIP® ES-310 Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172128. The device is classified under product code PIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EsoFLIP® ES-310 Balloon Catheter?

EsoFLIP® ES-310 Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Crospon, Ltd.. The 510(k) number is K172128.

When did EsoFLIP® ES-310 Balloon Catheter receive FDA 510(k) clearance?

EsoFLIP® ES-310 Balloon Catheter received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172128.

Who is the listed applicant for EsoFLIP® ES-310 Balloon Catheter?

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

What is the FDA product code for EsoFLIP® ES-310 Balloon Catheter?

The FDA product code for EsoFLIP® ES-310 Balloon Catheter is PIE.

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Crospon, Ltd.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。

K183072EndoFLIP SystemK170833EndoFLIP® System with FLIP Topography moduleK160725EndoFLIP

官方来源

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