510(k) K173614

Penumbra Coil 400, Ruby Coil System, POD System by Penumbra, Inc. — Product Code HCG

K173614 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Penumbra Coil 400, Ruby Coil System, POD System". The FDA issued a decision of Substantially Equivalent on Apr 17, 2018. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Penumbra, Inc. has 86 other 510(k) clearances on record.