QNR

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

Product code

QNR

Device name

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

Device class

Class 2

21 CFR

21 CFR 870.4100

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-05-20.

3 summaries are archived here for direct download.