MECC SET WITH BIOLINE COATING— 510(k) K083794

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K083794 for MECC SET WITH BIOLINE COATING, Substantially Equivalent on 2009-04-21. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2008-12-22
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hirrlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.