TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221— 510(k) K052570

Substantially Equivalent

Cardiacassist, Inc.

FDA 510(k) clearance K052570 for TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221, Substantially Equivalent on 2006-01-17. Applicant: Cardiacassist, Inc..

Clearance details

Applicant: Cardiacassist, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2005-09-19
Decision date: 2006-01-17
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.