Cleared Traditional

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

K230318 · Corcym S.r.l. · Cardiovascular

Apr 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K230318 is an FDA 510(k) clearance for the Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring, a Ring, Annuloplasty (Class II — Special Controls, product code KRH), submitted by Corcym S.r.l. (Saluggia, IT). The FDA issued a Cleared decision on April 7, 2023, 60 days after receiving the submission on February 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number	K230318 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2023
Decision Date	April 07, 2023
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF