FDA 510(k) Application Details - K180454

Device Classification Name	More FDA Info for this Device
510(K) Number	K180454
Device Name	Shockwave Medical Intravascular Lithotripsy (IVL) System
Applicant	Shockwave Medical, Inc. 48501 Warm Springs Blvd Suite 108 Fremont, CA 94539 US Other 510(k) Applications for this Company
Contact	Plessy Paul 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	02/20/2018
Decision Date	06/27/2018
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