Cleared Special

Traxcess 7 Mini XSoft Guidewire

K163154 · MicroVention, Inc. · Neurology
Dec 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K163154 is an FDA 510(k) clearance for the Traxcess 7 Mini XSoft 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 December 9, 2016, 29 days after receiving the submission on November 10, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K163154 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2016
Decision Date December 09, 2016
Days to Decision 29 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