FDA 510(k) Application Details - K093257

Device Classification Name	Catheter Introducer Kit   More FDA Info for this Device
510(K) Number	K093257
Device Name	Catheter Introducer Kit
Applicant	SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	BRANDON HANSEN Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	OFC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2009
Decision Date	03/26/2010
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