Cleared Traditional

CEREGLIDE 42 Intermediate Catheter (K241244) - FDA 510(k) Clearance

Also marketed or referenced as:
CEREGLIDE 57 Intermediate Catheter

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

K241244 · Cerenovus, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
167d
Days
Class 2
Risk

K241244 is an FDA 510(k) clearance for the CEREGLIDE 42 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 October 16, 2024 after a review of 167 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 K241244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2024
Decision Date October 16, 2024
Days to Decision 167 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
19d slower than avg
Panel avg: 148d · This submission: 167d
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 K241244.
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
8F Modified Sheath System
K240529 · Route 92 Medical, Inc. · Oct 2024
Next Generation Access Catheter
K234074 · Balt USA, LLC · Jul 2024
TracStar LDP Large Distal Platform
K240948 · Imperative Care, Inc. · Jun 2024