PKI

Fully Subcutaneous Implanted Hemodialysis Catheter

Product code

PKI

Device name

Fully Subcutaneous Implanted Hemodialysis Catheter

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

FDA classification definition

Provides access to the blood for hemodialysis or other chronic uses.

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