Cleared Traditional

Wedge Microcatheter

K172014 · MicroVention, Inc. · Cardiovascular
Apr 2018
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K172014 is an FDA 510(k) clearance for the Wedge Microcatheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on April 5, 2018, 276 days after receiving the submission on July 3, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K172014 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2017
Decision Date April 05, 2018
Days to Decision 276 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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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