LOX

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Product code

LOX

Device name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device class

Class 2

21 CFR

21 CFR 870.5100

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

10

Summaries archived here

10 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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

510(k) clearances, last 3 years (10)

Last three years. Most recent: 2026-08-14.

10 summaries are archived here for direct download.