Cleared Traditional

AZUR CX Detachable 18 Peripheral Coil System

K162524 · MicroVention, Inc. · Cardiovascular
Mar 2017
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K162524 is an FDA 510(k) clearance for the AZUR CX Detachable 18 Peripheral Coil System, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on March 3, 2017, 175 days after receiving the submission on September 9, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K162524 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2016
Decision Date March 03, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRD — Device, Vascular, For Promoting Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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