Cleared Special

K261889 - Trevo Trak 21 Microcatheter

K261889 is an FDA 510(k) clearance for Trevo Trak 21 Microcatheter, manufactured by Stryker Neurovascular. The device is a Class 2 Neurology device with product code QJP cleared through the Special 510(k) pathway after a 26-day FDA review.

K261889 · Stryker Neurovascular · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
26d
Days
Class 2
Risk

K261889 is an FDA 510(k) clearance for the Trevo Trak 21 Microcatheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on July 1, 2026 after a review of 26 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.

FDA 510(k) Submission Details - K261889

510(k) Number K261889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2026
Decision Date July 01, 2026
Days to Decision 26 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
123d faster than avg
Panel avg: 149d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

QJP Device Classification - Class 2, Special Controls

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 101
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K261889.
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K254178 · Asahi Intecc Co., Ltd. · May 2026
K261889 · Trevo Trak 21 Microcatheter
Download PDF FDA Summary Stryker Neurovascular