FDA 510(k)

卡彭蒂埃-愛德華斯物理環成形環 (4450)

K 號：K251688 · 2025-09-17

決定日期2025-09-17

產品代碼KRH

諮詢委員會履歷

決定相當於

器材摘要

Carpentier-Edwards Physio Annuloplasty Ring (4450) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251688. 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 Carpentier-Edwards Physio Annuloplasty Ring (4450)?

Carpentier-Edwards Physio Annuloplasty Ring (4450) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K251688.

When did Carpentier-Edwards Physio Annuloplasty Ring (4450) receive FDA 510(k) clearance?

Carpentier-Edwards Physio Annuloplasty Ring (4450) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251688.

Who is the listed applicant for Carpentier-Edwards Physio Annuloplasty Ring (4450)?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carpentier-Edwards Physio Annuloplasty Ring (4450)?

The FDA product code for Carpentier-Edwards Physio Annuloplasty Ring (4450) is KRH.

其他以 Edwards Lifesciences, LLC 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。

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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 K250859轉換麥卡锡二尖瓣環成形環 (TF)Genesee Biomedical, Inc.K232599轉換麥卡锡二尖瓣環成形環 (TF)Genesee Biomedical, Inc.

官方來源

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