PNE

Reprocessed Catheter Introducer

Product code

PNE

Device name

Reprocessed Catheter Introducer

Device class

Class 2

21 CFR

21 CFR 870.1340

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Introduce various cardiovascular catheters into the heart and cardiovascular system

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

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

Last three years. Most recent: 2026-01-07.

3 summaries are archived here for direct download.