FDA 510(k) Application Details - K221852

Device Classification Name	More FDA Info for this Device
510(K) Number	K221852
Device Name	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
Applicant	Shockwave Medical, Inc. 5403 Betsy Ross Dr Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Danica Van Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2022
Decision Date	08/16/2022
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