Cleared Traditional

CEREGLIDE 92 Intermediate Catheter (K230726) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230726 · Cerenovus, Inc. · Neurology device
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Nov 2023
Decision
258d
Days
Class 2
Risk

K230726 is an FDA 510(k) clearance for the CEREGLIDE 92 Intermediate Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Cerenovus, Inc. (Miami, US). The FDA issued a Cleared decision on November 29, 2023 after a review of 258 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 Cerenovus, Inc. devices

Submission Details

510(k) Number K230726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2023
Decision Date November 29, 2023
Days to Decision 258 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 148d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K230726.
Millipede 088 Access Catheter
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K231393 · Maduro Medical, Inc. · Nov 2023
Q Distal Access Catheter
K222948 · Mivi Neuroscience, Inc. · Sep 2023
Millipede 088 Access Catheter
K231802 · Perfuze, Ltd. · Sep 2023
SOFIA EX Intracranial Support Catheter
K230775 · MicroVention, Inc. · Sep 2023