510(k) K240193— R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)

Substantially Equivalent

Sorin Group Italia S.R.L.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2024-01-24
Decision date: 2024-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola ( Modena), IT

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.