QZU — Temporary Embolization Assist Device, Peripheral Class II
FDA product code QZU covers "Temporary Embolization Assist Device, Peripheral", a Class II medical device regulated under 21 CFR 870.3325. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QZU
- Device Class
- Class II
- Regulation Number
- 870.3325
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230064 | rapid medical | BraidE Embolization Assist Device | February 21, 2024 |