K082117

Substantially Equivalent

QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000

Applicant: Maquet Cardiopulmonary, AG
Product code: DTZ
Advisory panel: Cardiovascular
Date received: 2008-07-28
Decision date: 2009-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hirrlingen, DE

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

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.