QZU · Class II · 21 CFR 870.3325

FDA Product Code QZU: Temporary Embolization Assist Device, Peripheral

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.

Leading manufacturers include Rapid Medical , Ltd..

1
Total
0
Cleared
155d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Temporary Embolization Assist Device, Peripheral Devices (Product Code QZU)

1 devices
1–1 of 1
Not Cleared Feb 21, 2024
BraidE Embolization Assist Device
DEN230064
Rapid Medical , Ltd.
Cardiovascular · 155d

About Product Code QZU - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QZU since 2024, with 0 receiving FDA clearance (average review time: 155 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QZU devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →