Cleared Traditional

CELLO II Balloon Guide Catheter (K223275) - FDA 510(k) Clearance

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

K223275 · Fuji Systems Corporation · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2022
Decision
46d
Days
Class 2
Risk

K223275 is an FDA 510(k) clearance for the CELLO II Balloon Guide Catheter. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Fuji Systems Corporation (Nishi Shirakawa Gun, JP). The FDA issued a Cleared decision on December 9, 2022 after a review of 46 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fuji Systems Corporation devices

Submission Details

510(k) Number K223275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2022
Decision Date December 09, 2022
Days to Decision 46 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 148d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K223275.
SelectFlex Neurovascular Access System Family
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TracStar LDP Large Distal Platform
K231168 · Imperative Care, Inc. · May 2023
CEREGLIDE 71 Intermediate Catheter
K221930 · Cerenovus, Inc. · Mar 2023
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K221822 · Penumbra, Inc. · Nov 2022
Branchor Balloon Guide Catheter
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Route 92 Medical Full Length 070 Access System
K222743 · Route 92 Medical, Inc. · Oct 2022