FDA 510(k), K173614, Penumbra Coil 400, Ruby Coil System, POD System

510(K) Number: K173614
Device Name: Penumbra Coil 400, Ruby Coil System, POD System
Manufacturer: Penumbra, Inc.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 11/22/2017
Decision Date: 04/17/2018
Regulation Medical Specialty: Neurology

179 pages (392 of 571 original pages are fully redacted)