FDA 510(k) Application Details - K080891

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K080891
Device Name	Catheter, Ultrasound, Intravascular
Applicant	VOLCANO CORPORATION 2870 KILGORE RD. RANCHO CORDOVA, CA 95670 US Other 510(k) Applications for this Company
Contact	JENNIFER MOTTO Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2008
Decision Date	05/12/2008
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