Cleared Special

Traxcess 7 Mini Guidewire

K201487 · MicroVention, Inc. · Neurology
Jul 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201487 is an FDA 510(k) clearance for the Traxcess 7 Mini 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 July 2, 2020, 28 days after receiving the submission on June 4, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K201487 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2020
Decision Date July 02, 2020
Days to Decision 28 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