FDA Product Code PZS: Dual Lumen Ecmo Cannula
Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.
Leading manufacturers include Cardiacassist, Inc..
List of Dual Lumen Ecmo Cannula devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Dual Lumen Ecmo Cannula devices (product code PZS). 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 →