MEMO 4D— 510(k) K180411

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K180411 for MEMO 4D, Substantially Equivalent on 2018-03-16. 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: 2018-02-15
Decision date: 2018-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Saluggia, 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.