Cleared Traditional

CEREGLIDE 71 Intermediate Catheter (K221934) - FDA 510(k) Clearance

Also marketed or referenced as:
Cerenovus Aspiration Tubing Set

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

K221934 · Cerenovus, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
251d
Days
Class 2
Risk

K221934 is an FDA 510(k) clearance for the CEREGLIDE 71 Intermediate 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 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 K221934 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 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 K221934.
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
K230429 · Rapid Medical , Ltd. · Apr 2023
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
K223530 · Route 92 Medical, Inc. · Apr 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K230695 · Alembic, LLC · Apr 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · Alembic, LLC · Feb 2023
Penumbra System (Reperfusion Catheter RED 43)
K222808 · Penumbra, Inc. · Dec 2022
Tigertriever 13 Revascularization Device
K220808 · Rapid Medical , Ltd. · Jul 2022