ODY

Tunneled Catheter Remover

Product code

ODY

Device name

Tunneled Catheter Remover

Device class

Class 2

21 CFR

21 CFR 880.5970

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.

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