Not Cleared Direct

DEN230064 - BraidE Embolization Assist Device (FDA 510(k) Clearance)

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

DEN230064 · Rapid Medical , Ltd. · Cardiovascular device
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Feb 2024
Decision
155d
Days
Class 2
Risk

DEN230064 is an FDA 510(k) submission (not cleared) for the BraidE Embolization Assist Device. Classified as Temporary Embolization Assist Device, Peripheral (product code QZU), Class II - Special Controls.

Submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on February 21, 2024 after a review of 155 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3325 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

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Submission Details

510(k) Number DEN230064 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 19, 2023
Decision Date February 21, 2024
Days to Decision 155 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics

Device Classification

Product Code QZU Temporary Embolization Assist Device, Peripheral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3325
Definition A Temporary Coil Embolization Assist Device Is A Prescription Device Intended For Temporary Use In The Vasculature To Mechanically Assist In The Embolization Of Aneurysms With Embolic Coils. The Device Is Delivered Into The Vasculature With An Endovascular Approach. This Device Is Not Intended To Be Permanently Implanted And Is Removed From The Body When The Procedure Is Completed.
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 Cardiovascular devices follow this clearance model.