FDA 510(k) Application Details - K180958

Device Classification Name	More FDA Info for this Device
510(K) Number	K180958
Device Name	Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
Applicant	Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont, CA 94539 US Other 510(k) Applications for this Company
Contact	Cindy Morrow 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	04/12/2018
Decision Date	07/26/2018
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