K080592

Substantially Equivalent

HLM TUBING SET WITH BIOLINE COATING

Applicant: Maquet Cardiopulmonary, AG
Product code: DWE
Advisory panel: Cardiovascular
Date received: 2008-03-03
Decision date: 2008-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.