ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING— 510(k) K131666

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K131666 for ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING, Substantially Equivalent on 2013-07-05. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2013-06-07
Decision date: 2013-07-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Hechingen, DE

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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.