FDA 510(k) Application Details - K250385

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K250385
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Spectranetics 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	Katie Adamski Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2025
Decision Date	03/13/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review