Cleared Special

AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter

K200206 · Stryker Neurovascular · Neurology

Feb 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K200206 is an FDA 510(k) clearance for the AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on February 27, 2020, 30 days after receiving the submission on January 28, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K200206 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2020
Decision Date	February 27, 2020
Days to Decision	30 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