Cleared Traditional

K213838 - AneuGuide (FDA 510(k) Clearance)

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

K213838 · ArteryFlow Technology Co., Ltd. · Neurology device
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Jun 2022
Decision
174d
Days
Class 2
Risk

K213838 is an FDA 510(k) clearance for the AneuGuide. Classified as Software For Visualization Of Vascular Anatomy And Intravascular Devices (product code PZO), Class II - Special Controls.

Submitted by ArteryFlow Technology Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 1, 2022 after a review of 174 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 892.2050 - 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 ArteryFlow Technology Co., Ltd. devices

Submission Details

510(k) Number K213838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2021
Decision Date June 01, 2022
Days to Decision 174 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
26d slower than avg
Panel avg: 148d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZO Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning.
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.