FDA 510(k), K143218, Penumbra Smart Coil

510(K) Number: K143218
Device Name: Penumbra Smart Coil
Manufacturer: Penumbra, Inc.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 11/10/2014
Decision Date: 03/18/2015
Regulation Medical Specialty: Neurology

226 pages (1,871 of 2,097 original pages are fully redacted)