FDA Product Code QHW: Single Lumen Ecmo Cannula

ECMO requires specialized cannulas to establish extracorporeal blood flow. FDA product code QHW covers single-lumen ECMO cannulas used to drain venous blood or return oxygenated blood during extracorporeal membrane oxygenation.

These large-bore cannulas are inserted into central veins or arteries and connected to the ECMO circuit to provide venovenous or venoarterial extracorporeal support in patients with severe respiratory or cardiac failure. Single-lumen cannulas handle either drainage or return — distinct from dual-lumen cannulas that do both.

QHW devices are Class II medical devices, regulated under 21 CFR 870.4100 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic, Inc..