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