K141432

Substantially Equivalent

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH

Applicant: Maquet Cardiopulmonary, AG
Product 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.