FDA 510(k) Application Details - K200374

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K200374
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	Orit Yaniv 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	02/14/2020
Decision Date	12/14/2020
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