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..
FDA 510(k) Cleared Single Lumen Ecmo Cannula Devices (Product Code QHW)
About Product Code QHW - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QHW since 2022, with 3 receiving FDA clearance (average review time: 301 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QHW have taken an average of 216 days to reach a decision - down from 343 days historically, suggesting improved FDA processing for this classification.
QHW devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →