Product code QNR

Device name
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.4100
Review panel
CV
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.
Source
FDA openFDA device classification dataset