Product code OPR

Device name
Intrasaccular Flow Disruption Device
Medical specialty
Unknown
Device class
3
Review panel
NE
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Source
FDA openFDA device classification dataset