Cleared Special

K193034 - AXS Infinity LS Plus Long Sheath

K193034 is the FDA 510(k) clearance for AXS Infinity LS Plus Long Sheath by Stryker Neurovascular. It is a Class 2 Neurology device (product code DQY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K193034 · Stryker Neurovascular · Neurology device
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Nov 2019
Decision
29d
Days
Class 2
Risk

K193034 is an FDA 510(k) clearance for the AXS Infinity LS Plus Long Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on November 29, 2019 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Neurovascular devices

Submission Details

510(k) Number K193034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2019
Decision Date November 29, 2019
Days to Decision 29 days
Submission Type Special
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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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
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