FDA 510(k) Application Details - K094036

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K094036
Device Name	Catheter, Peripheral, Atherectomy
Applicant	SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 US Other 510(k) Applications for this Company
Contact	MICHAEL K HANDLEY 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	12/30/2009
Decision Date	01/25/2010
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