FDA 510(k) Application Details - K142116

Device Classification Name	Stylet, Catheter   More FDA Info for this Device
510(K) Number	K142116
Device Name	Stylet, Catheter
Applicant	SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	PHAROAH GARMA Other 510(k) Applications for this Contact
Regulation Number	870.1380   More FDA Info for this Regulation Number
Classification Product Code	DRB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2014
Decision Date	08/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review