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FDA 510(k)

TriMemo™ 適中硬度環狀縫合環

K 號:K260498 · 2026-04-14

申請人Corcym S.r.l.
決定日期2026-04-14
產品代碼KRH
諮詢委員會履歷
決定相當於

器材摘要

TriMemo™ 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 2026-04-14 under 510(k) number K260498. 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 TriMemo™ SEMIRIGID ANNULOPLASTY RING?

TriMemo™ SEMIRIGID ANNULOPLASTY RING is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Corcym S.r.l.. The 510(k) number is K260498.

When did TriMemo™ SEMIRIGID ANNULOPLASTY RING receive FDA 510(k) clearance?

TriMemo™ SEMIRIGID ANNULOPLASTY RING received FDA 510(k) clearance on 2026-04-14, under 510(k) number K260498.

Who is the listed applicant for TriMemo™ 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 TriMemo™ SEMIRIGID ANNULOPLASTY RING?

The FDA product code for TriMemo™ SEMIRIGID ANNULOPLASTY RING is KRH.

相關臨床試驗

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其他以 Corcym S.r.l. 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。

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。

官方來源

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