DEN230064 is an FDA 510(k) submission for the BraidE Embolization Assist Device. This device is classified as a Temporary Embolization Assist Device, Peripheral (Class II - Special Controls, product code QZU).
Submitted by Rapid Medical , Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on February 21, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3325. 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..
| 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 | — |
| Product Code | QZU — Temporary Embolization Assist Device, Peripheral |
| Device Class | Class II - 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. |