Device Classification Name |
temporary embolization assist device, peripheral
|
De Novo Number |
DEN230064 |
Device Name |
BraidE Embolization Assist Device |
Requester |
rapid medical ltd. |
carmel building, pob 337 |
yokneam,
IL
2069205
|
|
Contact |
ina gutman |
|
Regulation Number | 870.3325
|
Classification Product Code |
|
Date Received | 09/19/2023 |
Decision Date | 02/21/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|