FDA Product Code QNR: Blood Pump For Ecmo, Long-term (> 6 Hours) Use
ECMO provides prolonged cardiorespiratory support for patients with refractory heart or lung failure. FDA product code QNR covers blood pumps cleared for long-term ECMO use exceeding six hours.
These centrifugal or roller pumps drive extracorporeal blood flow through an oxygenator membrane, providing gas exchange and/or cardiac output support for days to weeks in patients with severe ARDS, cardiogenic shock, or as a bridge to transplantation.
QNR devices are Class II medical devices, regulated under 21 CFR 870.4100 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Cardiacassist, Inc., Abbott Medical and Medtronic, Inc..
List of Blood Pump For Ecmo, Long-term (> 6 Hours) Use devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Blood Pump For Ecmo, Long-term (> 6 Hours) Use devices (product code QNR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →