NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH— 510(k) K141432

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K141432 for NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH, Substantially Equivalent on 2014-07-07. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2014-05-30
Decision date: 2014-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Rastatt De-Bw, 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.