TruForm Sievers 心脏瓣膜成形环
K号: K202253 · 2020-10-06
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决定日期2020-10-06
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：
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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
TruForm Sievers Annuloplasty Ring 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 2020-10-06 under 510(k) number K202253. 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 TruForm Sievers Annuloplasty Ring?
TruForm Sievers Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2020-10-06. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K202253.
When did TruForm Sievers Annuloplasty Ring receive FDA 510(k) clearance?
TruForm Sievers Annuloplasty Ring received FDA 510(k) clearance on 2020-10-06, under 510(k) number K202253.
Who is the listed applicant for TruForm Sievers Annuloplasty Ring?
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 TruForm Sievers Annuloplasty Ring?
The FDA product code for TruForm Sievers Annuloplasty Ring 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。
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。
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 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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