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 (last 3 years): 1

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).

Official FDA classification page: OBK

Classification and pathway per current FDA publications. Data from openFDA (CC0).