PUU

Temporary Coil Embolization Assist Device

Product code

PUU

Device name

Temporary Coil Embolization Assist Device

Device class

Class 2

21 CFR

21 CFR 882.5955

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).