FDA 510(k) Application Details - K220544

Device Classification Name	More FDA Info for this Device
510(K) Number	K220544
Device Name	DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
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	02/25/2022
Decision Date	06/29/2022
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