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 C.R. Bard, Inc..