Cleared Special

Traxcess 14 SELECT Guidewire

K200547 · MicroVention, Inc. · Neurology
Apr 2020
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K200547 is an FDA 510(k) clearance for the Traxcess 14 SELECT Guidewire, a Guide, Wire, Catheter, Neurovasculature (Class II — Special Controls, product code MOF), submitted by MicroVention, Inc. (Aliso Veijo, US). The FDA issued a Cleared decision on April 16, 2020, 44 days after receiving the submission on March 3, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K200547 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2020
Decision Date April 16, 2020
Days to Decision 44 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