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

FDA product code QNR · 8 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.4100
Review panel
CV
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2021-03-26 – 2025-05-20

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.

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