VENOUS HARDSHELL CARDIOTOMY RESERVIORS— 510(k) K090534

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K090534 for VENOUS HARDSHELL CARDIOTOMY RESERVIORS, Substantially Equivalent on 2009-12-23. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2009-02-27
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Hirrlingen, DE

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.