FDA 510(k) Application Details - K170349

Device Classification Name	More FDA Info for this Device
510(K) Number	K170349
Device Name	RA-308 Excimer Laser System, Excimer Laser Catheter
Applicant	Ra Medical Systems, Inc. 1930 Kellogg Ave. Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Dean Irwin 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	02/03/2017
Decision Date	05/24/2017
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