K093730

Substantially Equivalent

PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)

Applicant: Edwards Lifesciences, LLC
Product code: DWF
Advisory panel: Cardiovascular
Date received: 2009-12-03
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Midvale, UT, 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.