Cleared Special

Trevo Trak 21 Microcatheter

K211594 · Stryker Neurovascular · Neurology

Nov 2021

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K211594 is an FDA 510(k) clearance for the Trevo Trak 21 Microcatheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on November 26, 2021, 186 days after receiving the submission on May 24, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K211594 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2021
Decision Date	November 26, 2021
Days to Decision	186 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures