PQK

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Product code

PQK

Device name

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Device class

Class 2

21 CFR

21 CFR 870.1252

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

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