510(k) K132166— VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT

Substantially Equivalent

Maquet Cardiopulmonary, AG

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2013-07-12
Decision date: 2013-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Rastatt De-Bw, DE

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.