FDA 510(k) Application Details - K233791

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K233791
Device Name	Guide, Wire, Catheter, Neurovasculature
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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2023
Decision Date	07/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review