FDA 510(k) Application Details - K212784

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K212784
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	Spectranetics, Inc. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	Jordan Baum Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2021
Decision Date	08/24/2022
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