Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring— 510(k) K230318

Substantially Equivalent

Corcym S.r.l.

FDA 510(k) clearance K230318 for Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring, Substantially Equivalent on 2023-04-07. Applicant: Corcym S.r.l..

Clearance details

Applicant
Corcym S.r.l.
Product code
Code KRH
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Saluggia, IT
Download summary PDFView on FDA.gov ↗

Adverse events under product code KRH

product code KRH
Death
45
Injury
2,235
Total
2,280

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.