DeviceClearance

K061369

Substantially Equivalent

TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

Applicant
Cardiacassist, Inc.
Product code
DWA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pittsburgh, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DWA

product code DWA
Death
15
Malfunction
1,654
Total
1,669

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.