Product code NUF

Device name
Catheter, Neurovasculature, Occluding Balloon
Medical specialty
Neurology
Device class
3
Regulation number
882.5150
Review panel
NE
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Call for PMAs - 12/26/96 per 61 FR 50708 on 9/27/96 - For the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management
Source
FDA openFDA device classification dataset