FDA 510(k) Application Details - K053460

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K053460
Device Name	Catheter, Peripheral, Atherectomy
Applicant	FOX HOLLOW TECHNOLOGIES 740 BAY ROAD REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	MELISSA MURPHY 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	12/13/2005
Decision Date	01/13/2006
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