Cleared Special

Traxcess .007 Mini Guidewire

K161803 · MicroVention, Inc. · Neurology
Sep 2016
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K161803 is an FDA 510(k) clearance for the Traxcess .007 Mini Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on September 30, 2016, 92 days after receiving the submission on June 30, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K161803 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2016
Decision Date September 30, 2016
Days to Decision 92 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MOF — Guide, Wire, Catheter, Neurovasculature
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330