Cleared Traditional

AXS Offset Delivery Assist Catheter

K163259 · Stryker Neurovascular · Cardiovascular
Jul 2017
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K163259 is an FDA 510(k) clearance for the AXS Offset Delivery Assist Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on July 28, 2017, 249 days after receiving the submission on November 21, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K163259 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2016
Decision Date July 28, 2017
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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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