Product code PKI

Device name

Fully Subcutaneous Implanted Hemodialysis Catheter

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5540

Review panel

GU

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset