Cleared Traditional

V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

K162999 · MicroVention, Inc. · Neurology

Mar 2017

Decision

152d

Days

Class 2

Risk

About This 510(k) Submission

K162999 is an FDA 510(k) clearance for the V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on March 29, 2017, 152 days after receiving the submission on October 28, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K162999 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2016
Decision Date	March 29, 2017
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF