PDU

Catheter For Crossing Total Occlusions

Product code

PDU

Device name

Catheter For Crossing Total Occlusions

Device class

Class 2

21 CFR

21 CFR 870.1250

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

5 (direct download)

510(k) clearances (all years, FDA)

58 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-28.

5 summaries are archived here for direct download.