Cleared Traditional

AXS Vecta 46 Intermediate Catheter

K202752 · Stryker Neurovascular · Neurology

Aug 2021

Decision

340d

Days

Class 2

Risk

About This 510(k) Submission

K202752 is an FDA 510(k) clearance for the AXS Vecta 46 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 August 27, 2021, 340 days after receiving the submission on September 21, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K202752 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2020
Decision Date	August 27, 2021
Days to Decision	340 days
Submission Type	Traditional
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