FDA 510(k) Application Details - DEN230064

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230064
Device Name	BraidE Embolization Assist Device
Applicant	Rapid Medical Ltd. Carmel Building, POB 337 Yokneam 2069205 IL Other 510(k) Applications for this Company
Contact	Ina Gutman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2023
Decision Date	02/21/2024
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review