OBK

Port, Protector/Cushion

Product code

OBK

Device name

Port, Protector/Cushion

Device class

Class 2

21 CFR

21 CFR 880.5965

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.

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