FDA 510(k) Application Details - K150201

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K150201
Device Name	Catheter, Percutaneous
Applicant	SPECTRANETICS, INC. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	Christine Godleski 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	01/29/2015
Decision Date	02/27/2015
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