FDA 510(k) Application Details - K093301

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K093301
Device Name	Catheter, Peripheral, Atherectomy
Applicant	EV3 INC 3033 Campus Drive Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	BRENDA JOHNSON 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	10/21/2009
Decision Date	11/06/2009
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	Y
Expedited Review