Cleared Special

AXS Vecta Aspiration System

K190212 · Stryker Neurovascular · Neurology

Apr 2019

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K190212 is an FDA 510(k) clearance for the AXS Vecta Aspiration System, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on April 24, 2019, 79 days after receiving the submission on February 4, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K190212 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2019
Decision Date	April 24, 2019
Days to Decision	79 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.