R501 aortic root cannula without vent line, R502 aortic root cannula with vent line— 510(k) K200612

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K200612 for R501 aortic root cannula without vent line, R502 aortic root cannula with vent line, Substantially Equivalent on 2020-11-17. 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: 2020-03-09
Decision date: 2020-11-17
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.