510(k) K102532— HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING

Substantially Equivalent

Maquet Cardiopulmonary, AG

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2010-09-03
Decision date: 2011-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hirrlingen, DE

Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.