Cleared Traditional

Trevo Trak 21 Microcatheter

K192122 · Stryker · Neurology
Nov 2019
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K192122 is an FDA 510(k) clearance for the Trevo Trak 21 Microcatheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Stryker (Freemont, US). The FDA issued a Cleared decision on November 22, 2019, 108 days after receiving the submission on August 6, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K192122 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2019
Decision Date November 22, 2019
Days to Decision 108 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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