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FDA 510(k)

WellsForm 三尖瓣环成形带（WF）

K号: K230679 · 2023-05-26

申请人Genesee Biomedical, Inc.
决定日期2023-05-26
产品代码KRH
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

WellsForm Tricuspid Annuloplasty Band (WF) is the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230679. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WellsForm Tricuspid Annuloplasty Band (WF)?

WellsForm Tricuspid Annuloplasty Band (WF) is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K230679.

When did WellsForm Tricuspid Annuloplasty Band (WF) receive FDA 510(k) clearance?

WellsForm Tricuspid Annuloplasty Band (WF) received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230679.

Who is the listed applicant for WellsForm Tricuspid Annuloplasty Band (WF)?

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

What is the FDA product code for WellsForm Tricuspid Annuloplasty Band (WF)?

The FDA product code for WellsForm Tricuspid Annuloplasty Band (WF) is KRH.

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Genesee Biomedical, 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。

K252917ATLAAS (无创左心耳附加装置) (AD)K250859Transform McCarthy 二尖瓣成形环（TF）K232599Transform McCarthy 二尖瓣成形环（TF）K202253TruForm Sievers 心脏瓣膜成形环K190506NeoForm 环形瓣膜K161815FlexForm 环形瓣膜和 FlexForm 环形瓣膜带

查看所有 7 个设备 →

相关器械（代码：KRH）

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。

K261707MEMO 4D Curve™ 半刚性二尖瓣环成形术环Corcym S.r.l.K260498TriMemo™ 半刚性环状成形器Corcym S.r.l.K253232Seguin 环缩环ABBOTT MEDICALK251982Edwards MC3 三尖瓣成形环（4900）Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859Transform McCarthy 二尖瓣成形环（TF）Genesee Biomedical, Inc.

官方来源

在 FDA 数据库中查看 →

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