Cleared Special

Cerenovus Large Bore Catheter (K233988) - FDA 510(k) Clearance

Also marketed or referenced as:
Cerenovus Aspiration Tubing Set

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233988 · Cerenovus, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
30d
Days
Class 2
Risk

K233988 is an FDA 510(k) clearance for the Cerenovus Large Bore Catheter. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Cerenovus, Inc. (Miami, US). The FDA issued a Cleared decision on January 17, 2024 after a review of 30 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 Cerenovus, Inc. devices

Submission Details

510(k) Number K233988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2023
Decision Date January 17, 2024
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 - NRY Catheter, Thrombus Retriever

All 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K233988.
Next Generation Aspiration Catheter
K234083 · Balt USA, LLC · Jul 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K233329 · Route 92 Medical, Inc. · Apr 2024
APRO 55 Catheter and Alembic Aspiration Tubing
K232971 · Alembic, LLC · Feb 2024
Millipede 070 Aspiration Catheter
K232524 · Perfuze, Ltd. · Oct 2023
Socrates Aspiration System
K223913 · Scientia Vascular, Inc. · Sep 2023
072 Aspiration System
K222786 · Q'Apel Medical, Inc. · Aug 2023