Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae— 510(k) K162215

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K162215 for Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae, Substantially Equivalent on 2017-06-16. Applicant: Sorin Group Italia S.R.L..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2016-08-08
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola, IT

Download summary PDF View on FDA.gov ↗

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.