FDA 510(k) Application Details - K210664

Device Classification Name	More FDA Info for this Device
510(K) Number	K210664
Device Name	DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Applicant	Ra Medical Systems, Inc. 2070 Las Palmas Drive Carlsbad, CA 92011 US Other 510(k) Applications for this Company
Contact	Jami Miller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2021
Decision Date	07/27/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review