NOO

Clamp, Dialysis Arm

Product code

NOO

Device name

Clamp, Dialysis Arm

Device class

Class 1

21 CFR

21 CFR 876.5540

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

FDA classification definition

The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.

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