FDA 510(k) Application Details - K250225

Device Classification Name	More FDA Info for this Device
510(K) Number	K250225
Device Name	Bolt Intravascular Lithotripsy (IVL) System
Applicant	Bolt Medical, Inc. 2131 Faraday Ave Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Stephanie Onstot 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	01/27/2025
Decision Date	03/25/2025
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