Cleared Traditional

AZUR Vascular Plug

K191680 · MicroVention, Inc. · Cardiovascular
Mar 2020
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K191680 is an FDA 510(k) clearance for the AZUR Vascular Plug, a Device, Vascular, For Promoting Embolization (Class II — Special Controls, product code KRD), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on March 20, 2020, 270 days after receiving the submission on June 24, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K191680 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2019
Decision Date March 20, 2020
Days to Decision 270 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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