ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)— 510(k) K140569

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K140569 for ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE), Substantially Equivalent on 2014-11-19. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2014-03-06
Decision date: 2014-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rastatt De-Bw, DE

Download summary PDF View on FDA.gov ↗

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.