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FDA 510(k)

Howell D.A.S.H Extraction Balloon with Multiple Sizing

K号: K173659 · 2018-07-06

申请人Wilson-Cook Medical, Inc.
决定日期2018-07-06
产品代码GCA
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

Howell D.A.S.H Extraction Balloon with Multiple Sizing is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K173659. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Howell D.A.S.H Extraction Balloon with Multiple Sizing?

Howell D.A.S.H Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K173659.

When did Howell D.A.S.H Extraction Balloon with Multiple Sizing receive FDA 510(k) clearance?

Howell D.A.S.H Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2018-07-06, under 510(k) number K173659.

Who is the listed applicant for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing?

The FDA product code for Howell D.A.S.H Extraction Balloon with Multiple Sizing is GCA.

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Wilson-Cook Medical, 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。

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相关器械（代码：GCA）

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。

K253013一次性结石取出球囊导管Zhejiang Soudon Medical Technology Co., Ltd.K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B, VDK-BAL-23-15/18/20-B, VDK-BAL-23-9/12/15-B, VDK-BAL-23-10/13/16-B, VDK-BAL-23-8.5/11.5/15-B, VDK-BAL-23-12/15/18-B, VDK-BAL-23-11/13/15-C, VDK-BAL-23-15/18/20-C, VDK-BAL-23-9/12/15-C, VDK-BAL-23-10/13/16-C, VDK-BAL-23-8.5/11.5/15-C, VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover球囊扩张导管Boston Scientific CorporationK210660结石取出球囊导管Anrei Medical (Hangzhou) Co., Ltd.K200173结石取出球囊Hangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.

官方来源

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