Cleared Special

MicroPlex Coil System (MCS) - HyperSoft 3D

K161452 · MicroVention, Inc. · Neurology
Aug 2016
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K161452 is an FDA 510(k) clearance for the MicroPlex Coil System (MCS) - HyperSoft 3D, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 31, 2016, 97 days after receiving the submission on May 26, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K161452 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2016
Decision Date August 31, 2016
Days to Decision 97 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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