FDA 510(k) Application Details - K161384

Device Classification Name	More FDA Info for this Device
510(K) Number	K161384
Device Name	Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable
Applicant	Shockwave Medical, Inc. 48501 Warm Springs Blvd, Suite 108 Fremont, CA 94539 US Other 510(k) Applications for this Company
Contact	NORA HADDING 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	05/19/2016
Decision Date	09/14/2016
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