FDA Product Code DQO: Catheter, Intravascular, Diagnostic
FDA product code DQO covers diagnostic intravascular catheters used for hemodynamic assessment and angiography.
These catheters are advanced into heart chambers or vessels to measure intracardiac and intravascular pressures, sample blood for oxygen saturation, and inject contrast for angiographic imaging. They are used in cardiac catheterization laboratory diagnostic studies.
DQO devices are Class II medical devices, regulated under 21 CFR 870.1200 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Terumo Corporation, Spectrum Vascular and Pfm Medical, Inc..
FDA 510(k) Cleared Catheter, Intravascular, Diagnostic Devices (Product Code DQO)
About Product Code DQO - Regulatory Context
510(k) Submission Activity
499 total 510(k) submissions under product code DQO since 1976, with 499 receiving FDA clearance (average review time: 121 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
FDA review times for DQO submissions have been consistent, averaging 133 days recently vs 121 days historically.
DQO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →