Cleared Special

K262277 - 70 NeuGlide Catheter

K262277 is an FDA 510(k) clearance for 70 NeuGlide Catheter, manufactured by Piraeus Medical, Inc.. The device is a Class 2 Neurology device with product code QJP cleared through the Special 510(k) pathway after a 60-day FDA review.

K262277 · Piraeus Medical, Inc. · Neurology device
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Sep 2026
Decision
60d
Days
Class 2
Risk

K262277 is an FDA 510(k) clearance for the 70 NeuGlide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Piraeus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 4, 2026 after a review of 60 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 Piraeus Medical, Inc. devices

FDA 510(k) Submission Details - K262277

510(k) Number K262277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2026
Decision Date September 04, 2026
Days to Decision 60 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
89d faster than avg
Panel avg: 149d · This submission: 60d
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 Consultant

Piraeus Medical
Sarah Kabanuk

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QJP Catheter, Percutaneous, Neurovasculature

All 99
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