CARDIOHELP SYSTEM— 510(k) K133598

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K133598 for CARDIOHELP SYSTEM, Substantially Equivalent on 2014-05-21. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTQ
Advisory panel: Cardiovascular
Date received: 2013-11-22
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.