510(k) K061369— TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

Substantially Equivalent

Cardiacassist, Inc.

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DWA
Advisory panel: Cardiovascular
Date received: 2006-05-17
Decision date: 2006-08-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

Adverse events under product code DWA

product code DWA

Death: 15
Malfunction: 1,654
Total: 1,669

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.