FDA 510(k)

TruForm Sievers 總合環

K 號：K202253 · 2020-10-06

決定日期2020-10-06

產品代碼KRH

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

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)K190506NeoForm 縫合環 K161815FlexForm 環狀環及 FlexForm 環狀帶

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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 MEDICAL K251982愛德華斯MC3 三尖瓣環成形環（4900）Edwards Lifesciences, LLC K251688卡彭蒂埃-愛德華斯物理環成形環 (4450)Edwards Lifesciences, LLC K250859轉換麥卡锡二尖瓣環成形環 (TF)Genesee Biomedical, Inc.

官方來源

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