510(k) DEN230064
- Device
- BraidE Embolization Assist Device
- Applicant
- Rapid Medical , Ltd.
- 510(k) number
- DEN230064
- Product code
- QZU
- Decision
- Unknown (DENG)
- Decision date
- 2024-02-21
- Date received
- 2023-09-19
- Regulation
- 870.3325
- Classification name
- Temporary Embolization Assist Device, Peripheral
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Ina Gutman
- Address
- Carmel Bldg., Pob 337 Yokneam IL 2069205 2069205
FDA Registration Numbers
- 3009957947
- 3015531723
Source Documents
510(k) summary PDF not indicated by FDA