FDA Product Code PDU: Catheter For Crossing Total Occlusions
Chronic total occlusions present the most challenging lesions in interventional cardiology. FDA product code PDU covers catheters specifically designed to cross total coronary or peripheral occlusions.
These dedicated CTO catheters have stiff, tapered tips and hydrophilic coatings that facilitate penetration and crossing of completely occluded vessel segments, enabling guidewire delivery distal to the occlusion for subsequent revascularization.
PDU devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Avinger, Inc., Baylis Medical Technologies, Inc. and LimFlow, Inc..
FDA 510(k) Cleared Catheter For Crossing Total Occlusions Devices (Product Code PDU)
About Product Code PDU - Regulatory Context
510(k) Submission Activity
57 total 510(k) submissions under product code PDU since 2003, with 57 receiving FDA clearance (average review time: 107 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.
FDA Review Time
Recent submissions under PDU have taken an average of 79 days to reach a decision - down from 108 days historically, suggesting improved FDA processing for this classification.
PDU devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →