Cleared Traditional

K163259 - AXS Offset Delivery Assist Catheter

K163259 is an FDA 510(k) clearance for AXS Offset Delivery Assist Catheter, manufactured by Stryker Neurovascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K163259 · Stryker Neurovascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
249d
Days
Class 2
Risk

K163259 is an FDA 510(k) clearance for the AXS Offset Delivery Assist Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 249 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Neurovascular devices

FDA 510(k) Submission Details - K163259

510(k) Number K163259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 125d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K163259.
M-CATH Microcatheter
K171176 · Acrostak (Schweiz) AG · Sep 2017
XableCath Support Catheter
K170041 · Xablecath, Inc. · Sep 2017
MAMBA and MAMBA FLEX Microcatheters
K171452 · Boston Scientific Corporation · Aug 2017
Rubicon 14, 18 and 35 Support Catheters
K171913 · Boston Scientific Corporation · Jul 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653 · Codman & Shurtleff, Inc. · Jul 2017
ACUITY Pro Lead Delivery System
K171612 · Boston Scientific Corporation · Jun 2017