FDA 510(k) Application Details - K203365

Device Classification Name	More FDA Info for this Device
510(K) Number	K203365
Device Name	Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ 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	11/16/2020
Decision Date	04/22/2021
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