DeviceClearance

K233819

Substantially Equivalent

Fogarty Venous Thrombectomy Catheters

Applicant
Edwards Lifesciences, LLC
Product code
DXE
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXE

product code DXE
Death
27
Injury
258
Malfunction
2,266
Total
2,551

Source: openFDA MAUDE database, through . 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.