FDA 510(k) Application Details - K081626

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K081626
Device Name	Catheter, Ultrasound, Intravascular
Applicant	VASONOVA INC. 1368 BORDEAUX DR., SUITE 100 SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	SORIN GRUNWALD 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	06/10/2008
Decision Date	10/15/2008
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