PDU · Class II · 21 CFR 870.1250

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. and C.R. Bard, Inc..

3
Total
3
Cleared
158d
Avg days
2021
Since

List of Catheter For Crossing Total Occlusions devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
K230594
Avinger, Inc.
Cardiovascular · 53d
Cleared Jan 06, 2022
Tigereye CTO-Crossing Catheter
K212468
Avinger, Inc.
Cardiovascular · 153d
Cleared Aug 12, 2021
Crosser iQ CTO Recanalization System
K203363
C.R. Bard, Inc.
Cardiovascular · 269d

How to use this database

This page lists all FDA 510(k) submissions for Catheter For Crossing Total Occlusions devices (product code PDU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →