QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS— 510(k) K132829

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K132829 for QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS, Substantially Equivalent on 2013-10-08. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2013-09-09
Decision date: 2013-10-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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.