BraidE Embolization Assist Device
FDA 510(k) clearance DEN230064 · decided 2024-02-21
Clearance details
- K-number
- DEN230064
- Device name
- BraidE Embolization Assist Device
- Applicant
- Rapid Medical Ltd.
- Decision
- Unknown
- Date received
- 2023-09-19
- Decision date
- 2024-02-21
- Days to decision
- 155 days
- Clearance type
- Direct
- Product code
- QZU
- Device class
- 2
- Regulation number
- 870.3325
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Yokneam, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.