Device type
Catheter For Crossing Total Occlusions
Product code PDU · Class II · 21 CFR 870.1250 · Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Recent 510(k)s
Aug 28, 2026
K262013
Kiba CTO Crossing Catheter
Reflow Medical, Inc.
- PDU
- Class II
Recent recalls
No recalls in the archive for PDU.