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FDA 510(k)

FlexForm 環狀環及 FlexForm 環狀帶

K 號：K161815 · 2016-10-12

申請人Genesee Biomedical, Inc.
決定日期2016-10-12
產品代碼KRH
諮詢委員會履歷
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Genesee Biomedical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252917ATLAAS (無創傷左心耳附屬結構系統) (AD)K250859轉換麥卡锡二尖瓣環成形環 (TF)K232599轉換麥卡锡二尖瓣環成形環 (TF)K230679WellsForm 三尖瓣環成形帶 (WF)K202253TruForm Sievers 總合環K190506NeoForm 縫合環

查看所有 7 項裝置 →

相關器械（代碼：KRH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261707MEMO 4D Curve™ 半硬性二尖瓣環Corcym S.r.l.K260498TriMemo™ 適中硬度環狀縫合環Corcym S.r.l.K253232西京環狀環ABBOTT MEDICALK251982愛德華斯MC3 三尖瓣環成形環（4900）Edwards Lifesciences, LLCK251688卡彭蒂埃-愛德華斯 物理環成形環 (4450)Edwards Lifesciences, LLCK250859轉換麥卡锡二尖瓣環成形環 (TF)Genesee Biomedical, Inc.

官方來源

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