DEN230064
- 510(k) number
- DEN230064
- Device name
- BraidE Embolization Assist Device
- Applicant
- Rapid Medical Ltd. IL
- Product code
- QZU — Temporary Embolization Assist Device, Peripheral
- Decision date
- 2024-02-21
- Date received
- 2023-09-19
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN230064
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.