Cleared Traditional

CEREGLIDE 71 Intermediate Catheter (K221930) - FDA 510(k) Clearance

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

K221930 · Cerenovus, Inc. · Neurology device
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Mar 2023
Decision
251d
Days
Class 2
Risk

K221930 is an FDA 510(k) clearance for the CEREGLIDE 71 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 March 9, 2023 after a review of 251 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 K221930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date March 09, 2023
Days to Decision 251 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
103d slower than avg
Panel avg: 148d · This submission: 251d
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 K221930.
Route 92 Medical Full Length 054 Access System
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SelectFlex Neurovascular Access System Family
K230322 · Q'Apel Medical, Inc. · Jun 2023
TracStar LDP Large Distal Platform
K231168 · Imperative Care, Inc. · May 2023
CELLO II Balloon Guide Catheter
K223275 · Fuji Systems Corporation · Dec 2022
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K221822 · Penumbra, Inc. · Nov 2022
Branchor Balloon Guide Catheter
K221951 · Asahi Intecc Co., Ltd. · Oct 2022