Cleared Traditional

AXS Vecta Aspiration Catheter

K190833 · Stryker Neurovascular · Neurology
Dec 2019
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K190833 is an FDA 510(k) clearance for the AXS Vecta Aspiration Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on December 15, 2019, 258 days after receiving the submission on April 1, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K190833 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2019
Decision Date December 15, 2019
Days to Decision 258 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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