Product code QZU

Device name

Temporary Embolization Assist Device, Peripheral

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.3325

Review panel

CV

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 vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature 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