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FDA 510(k)

三重提取球囊，多尺寸

K号: K193344 · 2019-12-13

申请人Wilson-Cook Medical, Inc.
决定日期2019-12-13
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

Tri-Ex 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 2019-12-13 under 510(k) number K193344. 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 Tri-Ex Extraction Balloon with Multiple Sizing?

Tri-Ex Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K193344.

When did Tri-Ex Extraction Balloon with Multiple Sizing receive FDA 510(k) clearance?

Tri-Ex Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193344.

Who is the listed applicant for Tri-Ex 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 Tri-Ex Extraction Balloon with Multiple Sizing?

The FDA product code for Tri-Ex 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。

K253302Hemospray 内镜止血夹 (HEMO-[X])K243568Teslatome 双极肛门括约肌刀；Tesla BiCord 主动线缆K213356Entuit PEG，Entuit PEGJK212323Instinct Plus Endoscopic Clipping DeviceK201322Entuit 鼻空肠喂养管K200972Hemospray 内镜止血夹

查看所有 32 个设备 →

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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