Product code NPE

Device name

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Medical specialty

Unknown

Device class

3

Review panel

NE

Implant

N

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations.

Source

FDA openFDA device classification dataset