OPR

Intrasaccular Flow Disruption Device

Product code: OPR
Device name: Intrasaccular Flow Disruption Device
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Implant

FDA classification definition

An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.

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

Official FDA classification page: OPR

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