FDA 510(k)

结石取出球囊导管

K号: K210660 · 2021-04-27

决定日期2021-04-27

产品代码GCA

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决定实质等同

器械摘要

Stone Retrieval Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K210660. 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 Stone Retrieval Balloon Catheter?

Stone Retrieval Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210660.

When did Stone Retrieval Balloon Catheter receive FDA 510(k) clearance?

Stone Retrieval Balloon Catheter received FDA 510(k) clearance on 2021-04-27, under 510(k) number K210660.

Who is the listed applicant for Stone Retrieval Balloon Catheter?

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

What is the FDA product code for Stone Retrieval Balloon Catheter?

The FDA product code for Stone Retrieval Balloon Catheter is GCA.

列明Anrei Medical (Hangzhou) Co., 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。

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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 Corporation K200173结石取出球囊Hangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.K193344三重提取球囊，多尺寸Wilson-Cook Medical, Inc.

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