Product code PUU

Device name

Temporary Coil Embolization Assist Device

Medical specialty

Neurology

Device class

2

Regulation number

882.5955

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.

Source

FDA openFDA device classification dataset