Cleared Traditional

K240971 - 87 NeuGlide Catheter

K240971 is an FDA 510(k) clearance for 87 NeuGlide Catheter, manufactured by Piraeus Medical. The device is a Class 2 Neurology device with product code QJP cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K240971 · Piraeus Medical · Neurology device
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Dec 2024
Decision
241d
Days
Class 2
Risk

K240971 is an FDA 510(k) clearance for the 87 NeuGlide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Piraeus Medical (Maple Grove, US). The FDA issued a Cleared decision on December 6, 2024 after a review of 241 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Piraeus Medical devices

FDA 510(k) Submission Details - K240971

510(k) Number K240971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2024
Decision Date December 06, 2024
Days to Decision 241 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
93d slower than avg
Panel avg: 148d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 91
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K240971.
Echo Intracranial Base Catheter
K241637 · Stryker Neurovascular · Dec 2024
Broadway 8 Catheter
K241768 · Stryker Neurovascular · Dec 2024
Access25™ Delivery Microcatheter
K242033 · Penumbra, Inc. · Dec 2024
Socrates 38 Catheter
K242301 · Scientia Vascular, Inc. · Dec 2024
Neurovascular Access System Family
K240746 · Q'Apel Medical, Inc. · Nov 2024
Zipline Access Catheter
K240711 · Perfuze, Ltd. · Oct 2024