FDA 510(k)

Memo 3D 半刚性瓣环；Memo 3D ReChord 半刚性瓣环；Memo 4D 半刚性瓣环

K号: K230318 · 2023-04-07

决定日期2023-04-07

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

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring is the device name listed in this FDA 510(k) record. The listed applicant is Corcym S.r.l.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K230318. 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 Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring?

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Corcym S.r.l.. The 510(k) number is K230318.

When did Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring receive FDA 510(k) clearance?

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring received FDA 510(k) clearance on 2023-04-07, under 510(k) number K230318.

Who is the listed applicant for Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring?

The FDA 510(k) record lists Corcym S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring?

The FDA product code for Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring is KRH.

列明Corcym S.r.l.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。

K261707MEMO 4D Curve™ 半刚性二尖瓣环成形术环 K260498TriMemo™ 半刚性环状成形器

官方来源

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