Cleared Traditional

VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)

K192135 · MicroVention, Inc. · Neurology
Dec 2019
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K192135 is an FDA 510(k) clearance for the VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on December 24, 2019, 139 days after receiving the submission on August 7, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K192135 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2019
Decision Date December 24, 2019
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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