FDA 510(k)

FlexForm 环形瓣膜和 FlexForm 环形瓣膜带

K号: K161815 · 2016-10-12

决定日期2016-10-12

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

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band 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 2016-10-12 under 510(k) number K161815. 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 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K161815.

When did FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band receive FDA 510(k) clearance?

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band received FDA 510(k) clearance on 2016-10-12, under 510(k) number K161815.

Who is the listed applicant for FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

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 FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band?

The FDA product code for FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is KRH.

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）K230679WellsForm 三尖瓣环成形带（WF）K202253TruForm Sievers 心脏瓣膜成形环 K190506NeoForm 环形瓣膜

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官方来源

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