PPN

Percutaneous Catheter, Ultrasound

Product code

PPN

Device name

Percutaneous Catheter, Ultrasound

Device class

Class 2

21 CFR

21 CFR 870.1250

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

6

Summaries archived here

6 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.

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

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-08-24.

6 summaries are archived here for direct download.