TANDEMHEART FEMORAL ARTERIAL CANNULA SET— 510(k) K120543

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K120543 for TANDEMHEART FEMORAL ARTERIAL CANNULA SET, Substantially Equivalent on 2012-05-30. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2012-02-23
Decision date: 2012-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

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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.