MEMO 3D ReChord— 510(k) K142221

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K142221 for MEMO 3D ReChord, Substantially Equivalent on 2014-08-29. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code KRH
Advisory panel: Cardiovascular
Date received: 2014-08-12
Decision date: 2014-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Saluggia Vercelli, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.