inforMED
QNRClass IILife-sustaining

Blood Pump For Ecmo, Long-term (> 6 Hours) Use

Cardiovascular · 21 CFR 870.4100

A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

MDR events386All time
Recalls2All time
Registered firms16Currently listed
510(k) clearances8All time