Cleared Special

MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)

K153594 · MicroVention, Inc. · Neurology
Jan 2016
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K153594 is an FDA 510(k) clearance for the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES), a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on January 22, 2016, 37 days after receiving the submission on December 16, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K153594 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2015
Decision Date January 22, 2016
Days to Decision 37 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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