FDA 510(k)

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

K-번호: K230318 · 2023-04-07

결정일2023-04-07

제품 코드KRH

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Corcym S.r.l.를 신청인으로 등재한 기타 기록

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ring K260498TriMemo™ SEMIRIGID ANNULOPLASTY RING

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