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., Spectranetics Corp. and Ra Medical Systems,Inc.
58
Total
58
Cleared
106d
Avg days
2003
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg
78d
recently vs 108d historically
FDA 510(k) Cleared Catheter For Crossing Total Occlusions Devices (Product Code PDU)
58 devices
Cleared
Aug 28, 2026
Kiba CTO Crossing Catheter
Reflow Medical, Inc.
Cardiovascular
74d
Cleared
Sep 22, 2025
Santreva™-ATK Endovascular Revasculariztion Catheter
AngioSafe, Inc.
Cardiovascular
59d
Cleared
Sep 11, 2025
PowerWire® 14 Radiofrequency Guidewire Kit
Baylis Medical Technologies, Inc.
Cardiovascular
149d
Cleared
May 31, 2025
LimFlow ARC
LimFlow, Inc.
Cardiovascular
29d
Cleared
Feb 28, 2024
PowerWire Radiofrequency Guidewire Kit
Baylis Medical Technologies, Inc.
Cardiovascular
188d
Cleared
Aug 28, 2023
SoundBite® Crossing System XS Peripheral
Soundbite Medical Solutions, Inc.
Cardiovascular
221d
Cleared
Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
Avinger, Inc.
Cardiovascular
53d
Cleared
Jan 19, 2023
Tunnel Crossing Catheter
Tractus Vascular, LLC
Cardiovascular
272d
Cleared
Aug 31, 2022
LimFlow ARC
LimFlow, Inc.
Cardiovascular
96d
Cleared
Jun 29, 2022
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
Ra Medical Systems,Inc
Cardiovascular
124d
Cleared
Mar 01, 2022
GoBack Crossing Catheter
Upstream Peripheral Technologies, Ltd.
Cardiovascular
264d
Cleared
Jan 06, 2022
Tigereye CTO-Crossing Catheter
Avinger, Inc.
Cardiovascular
153d
Cleared
Aug 12, 2021
Crosser iQ CTO Recanalization System
C.R. Bard, Inc.
Cardiovascular
269d
Cleared
Jul 27, 2021
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Ra Medical Systems,Inc
Cardiovascular
144d
Cleared
Apr 20, 2021
SoundBite Crossing System - Peripheral (14P)
Soundbite Medical Solutions, Inc.
Cardiovascular
29d
Cleared
Sep 10, 2020
Tigereye CTO-Crossing Catheter
Avinger, Inc.
Cardiovascular
114d
Cleared
Jan 17, 2020
SoundBite Console, SoundBite Active Wire 18
Soundbite Medical Solution, Inc.
Cardiovascular
156d
Cleared
Jan 21, 2019
XableCath Crossing Catheter
Xablecath, Inc.
Cardiovascular
48d
Cleared
May 24, 2017
RA-308 Excimer Laser System, Excimer Laser Catheter
Ra Medical Systems,Inc
Cardiovascular
110d
Cleared
Dec 02, 2016
Pioneer Plus Catheter
Philips Volcano
Cardiovascular
94d
Cleared
May 24, 2016
CROSSER CTO Recanalization Catheter
Bard Peripheral Vacular, Inc.
Cardiovascular
26d
Cleared
May 19, 2015
ELITECROSS Support Catheter
Cordis Corporation, A Johnson & Johnson Company
Cardiovascular
112d
Cleared
Apr 29, 2015
OUTBACK Elite Re-Entry Catheter
Cordis Corporation, A Johnson & Johnson Co.
Cardiovascular
30d
Cleared
Nov 14, 2014
MICRO GUIDE CATHETER ELITE
Cordis Corp., A Johnson & Johnson Co.
Cardiovascular
266d
About Product Code PDU - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code PDU since 2003, with 58 receiving FDA clearance (average review time: 106 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA 510(k) Review Time - PDU Product Code
Recent submissions under PDU have taken an average of 78 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 →