K102726

Substantially Equivalent

CARDIOHELP SYSTEM

Applicant: Maquet Cardiopulmonary, AG
Product code: DTQ
Advisory panel: Cardiovascular
Date received: 2010-09-21
Decision date: 2011-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hirrlingen, DE

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.