PFH

Venous Window Needle Guide

Product code

PFH

Device name

Venous Window Needle Guide

Device class

Class 2

21 CFR

21 CFR 876.5540

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

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

FDA classification definition

For use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or buttonhole method of needle insertion.

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