FDA 510(k) Application Details - K243757

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K243757
Device Name	Catheter, Percutaneous
Applicant	Shockwave Medical, Inc. 5403 Betsy Ross Drive Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Renee Maack Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2024
Decision Date	05/02/2025
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