Cleared Traditional

K183463 - AXS Catalyst Distal Access Catheter 068...

K183463 is the FDA 510(k) clearance for AXS Catalyst Distal Access Catheter 068... by Stryker. It is a Class 2 Neurology device (product code DQY) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K183463 · Stryker · Neurology device
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Mar 2019
Decision
89d
Days
Class 2
Risk

K183463 is an FDA 510(k) clearance for the AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access C.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on March 13, 2019 after a review of 89 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker devices

Submission Details

510(k) Number K183463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2018
Decision Date March 13, 2019
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Neurology devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K183463.
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