K010737

Substantially Equivalent

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924

Applicant: Medtronic Cardiac Surgical Products
Product code: DWF
Advisory panel: Cardiovascular
Date received: 2001-03-12
Decision date: 2001-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

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.