510(k) DEN170064

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

April 24, 2019

Date Received

September 28, 2017

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Temporary Coil Embolization Assist Device

Device Class

Class II

Regulation Number

882.5955

Review Panel

NE

Submission Type

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.