JOSTRA HLM TUBING SET— 510(k) K053025

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K053025 for JOSTRA HLM TUBING SET, Substantially Equivalent on 2005-11-10. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DWE
Advisory panel: Cardiovascular
Date received: 2005-10-27
Decision date: 2005-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, IA, US

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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.