PUU · Class II · 21 CFR 882.5955

FDA Product Code PUU: Temporary Coil Embolization Assist Device

A Temporary Coil Embolization Assist Device Is A Prescription Device Intended For Temporary Use In The Neurovasculature To Mechanically Assist In The Embolization Of Intracranial Aneurysms With Embolic Coils. The Device Is Delivered Into The Neurovasculature With An Endovascular Approach. This Device Is Not Intended To Be Permanently Implanted And Is Removed From The Body When The Procedure Is Completed.

1
Total
0
Cleared
573d
Avg days
2019
Since

FDA 510(k) Cleared Temporary Coil Embolization Assist Device Devices (Product Code PUU)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code PUU - Regulatory Context