Cleared Special

Traxcess Pro 14 Guidewire

K153053 · MicroVention, Inc. · Neurology
Dec 2015
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K153053 is an FDA 510(k) clearance for the Traxcess Pro 14 Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by MicroVention, Inc. (Tustin, US). The FDA issued a Cleared decision on December 29, 2015, 70 days after receiving the submission on October 20, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K153053 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2015
Decision Date December 29, 2015
Days to Decision 70 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